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QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Manager of Regulatory Affairs. This role will manage and support a team of managers and employees of different levels. You will be responsible for developing and implementing local strategy and leading the day-to-day regulatory affairs on base business operations and new product development projects within the Transfusion Medicine Business Unit. This position is remote eligible, with a strong preference for candidates who reside in Raritan, NJ; Rochester, NY; or Pompano Beach, FL Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks. Interact with US FDA and/or EU Notified Body regulatory personnel (including Corporate International RA and/or country RA) to define submission content, expedite pending applications, and resolve regulatory matters. Responsible for the final review of critical regulatory documents planned for regulatory submissions and responses to regulatory agencies as needed. Make judgments about the operational impact of proposed actions, and identify, and interact with appropriate resources to successfully achieve company and regulatory strategy objectives. Reviews/ interprets product-specific regulatory issues that may have a material impact on the business, the corporation, or the customer; develop strategic and tactical responses to influence a reasonable and compliant regulatory environment. Represent QuidelOrtho to US and EU regulatory agencies and interact with Health ministry personnel to expedite pending applications, resolve regulatory matters, and manage development meetings for regulatory submissions. Identify and/ or lead process improvement projects to streamline current activities and increase department efficiencies. Development goals, such as webinars, reviewing FDA website and articles, reading journals, and attendance at industry meetings, to expand knowledge and skill set in Regulatory affairs. Coach, mentor junior staff. Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risks and appropriate timing for approvals for planning purposes. Perform other work-related duties as assigned. Required: Bachelor's degree in a scientific or related discipline; or equivalent combination of education and experience. 10 years+ of experience in a regulated In Vitro Diagnostics and/ or Biologics Industry. 7+ years of experience developing and executing regulatory strategies for complex projects under product development or post-market changes requiring a US FDA submission (510(k), PMA and BLA or associated supplements and Annual Reports). Review and approval of product labeling and promotional and advertisement brochures and multimedia content. Coordinate and submit Pre-Sub meeting requests and associated regulatory strategic information and direct interaction with FDA product review branch(s). Previous people management experience. Excellent interpersonal, teamwork, and verbal/written communication skills. Good organizational skills and an ability to manage multiple tasks/projects/priorities. The ability to demonstrate model behavior and understand priorities and encourage others to drive for results will be needed. Ability to mentor and coach junior level staff as well as cross-train with peers. This position is not currently eligible for visa sponsorship. Preferred Direct experience with FDA CBER. Experience hosting or supporting Pre-Approval Inspections for either FDA, EU Notified Bodies or both. RAC (Regulatory Affairs Certification). Medical Device and/ or Pharmaceutical Industry experience is highly desirable. CE Mark under IVDD and current IVDR requirements, Canadian Licensing, and Rest of World (ROW) registrations is a plus. Use of Process Excellence (PEx) tools for process improvement initiatives. Internal Partners: Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality/Manufacturing Quality, Regulatory Affairs Managers/Directors, QO International and Regional Regulatory Affairs groups External Partners: Regulators in worldwide markets, for example TUV/BSI, FDA, Health Canada, etc. Third Party Contract Manufacturers and Suppliers. Use of a computer is required. Traditional office workspace or remote home office location. On occasion, may require up to 20% of domestic/international travel. The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $155,677.15 - $202,380.30 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate. QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at _. #LI-HF1

We're currently looking for individuals across the country to take part in remote paid research, including remote focus groups, product trials, and consumer studies.Earn up to $750 a week in your free time by providing feedback on everyday products and services.If you're comfortable sharing your opi

The Project Coordinator is a key contributor allocated to manage a set of assigned administrative responsibilities through project data entry preparation, billing, tracking, and assisting with the documentation of close out procedures.This individual will collaborate with the sales & service teams a

Job Opportunity At University Of Rochester.As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better.Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability.Together, we will set the highest stand

We need a Payroll Business Analyst for an Oracle Cloud implementation.Public sector experience a plus.Experience with the HR module a plus.Any PM experience is also a plus.Prior PeopleSoft or Oracle ERP experience is a plus.Open to occasional travel onsite in Rochester, NY.Location in the Eastern ti

Lumina Agency Inc is a forward-thinking organization dedicated to delivering structured, efficient, and high-quality project solutions for our clients.We value precision, collaboration, and professional growth, creating an environment where individuals can contribute meaningfully while developing lo

Senior Administrative Assistant.Become an integral part of Consumer & Community Banking team where you will have the opportunity to work in a fast-paced organization and each day will be unique! This role provides a platform for professional growth and skill enhancement.Be part of a team that is res

Senior Administrative Assistant.Become an integral part of Consumer & Community Banking team where you will have the opportunity to work in a fast-paced organization and each day will be unique! This role provides a platform for professional growth and skill enhancement.Be part of a team that is res

We are looking for an experienced individual to support "C Suite" leadership.If you thrive working in a fast paced environment, anticipate needs, manage complexity with confidence, and take pride in being the trusted right hand to senior leadership, you will want to align yourself with thi

Contract: 06 Months of contract.We are seeking a contract engineer or data analyst to complete the implementation of the coating thin film data analysis solution.The system automates coating run data review and disposition decisions, reducing manual engineering effort.This position will take over da

We are hiring a junior Data Analyst/Engineer to support data management and transformation efforts in a manufacturing environment.This role involves working with large datasets, organizing and validating data, and converting unstructured data into clean, usable formats.Clean, organize, and validate

Commercial Flooring Account Executive / Project Manager.Are you someone who enjoys building trusted business relationships, uncovering customer needs, and seeing projects through from first conversation to final completion?.TES Staffing is working with a large commercial flooring headquartered in Ro

Provide clerical support to the Provost and Vice President of Academic Affairs (PVPAA).Assist Academic Affairs Coordinator in day-to-day division responsibilities.Provide coverage in absence of Academic Affairs Coordinator.Provide clerical support, which includes, but is not limited to: answering an

Telecom Broadband Project Manager.We are currently seeking a Telecom Project Manager to support our Telecom division.This position is hybrid and can sit at any of our LiRo offices.Come join our team! We are looking to build services and capabilities through the growth of our key asset- our staff.Ran

We are looking for experienced landscape and/or irrigation installers who are looking for a change to join our landscape lighting team.The work is outdoors so you can still enjoy working outside and utilizing your skills while taking on a lighter task of installing landscape lighting and wiring.Work

Our client is seeking a highly experienced Senior Project Manager to lead large-scale capital projects domestically and internationally, including a major Hyderabad office development (~160,000 SF supporting ~800 headcount).This role operates as a sole practitioner (owner’s representative) respons

Senior Project Manager – MEP (Healthcare Construction).Vehicle Allowance + $80/month Phone Allowance.No travel beyond commute to project site (mileage reimbursement provided).This role will oversee large-scale healthcare commercial construction projects, specifically mechanical, plumbing, and MEP

Senior Highway Project Manager (PE) / Senior Transportation Project Manager.If you've built your career managing construction inspection work — and you're ready for a role with more scope, more influence, and a team that actually invests in its people — this is worth a look.A well-established We

Our client is seeking a highly experienced Senior Project Manager to lead large-scale capital projects domestically and internationally, including a major Hyderabad office development (~160,000 SF supporting ~800 headcount).This role operates as a sole practitioner (owner’s representative) respons

Construction Project Safety Manager.Montante Construction is seeking a Construction Project Safety Manager to join our growing team! If your skills, experience, and passion for safety at the job site align with this position, we would love to hear from you!.Montante Construction is a full-service co

Judge Direct Placement is seeking an Operations Manager in Rochester, NY area! They will be responsible for the day-to-day warehouse and fulfillment operations at the facility, ensuring safe, efficient, and high-quality execution across all inbound, outbound, and inventory processes.Work with the Di

Rochester, NY (In-person, travel within district required).Rochester, NY market—an already.This is an opportunity to step into a successful market and take it to the next level through leadership, development, and operational excellence.Consistent hours – restaurants close by 9–10 PM.Autonomy

Where state and federal laws/regulations allow, accountable for performing day-to-day non-clinical pharmacy operations, administrative activities; Ensures efficient pharmacy workflow and a positive patient experience.Serves as a full-time certified pharmacy technician.Responsible for operating pharm

World Professionals is seeing a Senior Manufacturing Operations Manager for our client in Rochester NY.This is an on-site position with a premier manufacturing company.If you are interested in being a part of a well-established and growing manufacturing organization, leading a high-performing produc

We are supporting a growing Westchester County General Contractor seeking a Project Manager to join their team and oversee the successful delivery of construction projects throughout Westchester, the Bronx, and the surrounding areas.Due to continued growth and an expanding pipeline of work, the comp

Our client is seeking a highly experienced Senior Project Manager to lead large-scale capital projects domestically and internationally, including a major Hyderabad office development (~160,000 SF supporting ~800 headcount).This role operates as a sole practitioner (owner’s representative) respons

This role requires a strong leader with proven experience managing technical teams, driving project execution, coordinating with customers, and ensuring successful delivery of engineering programs from concept through manufacturing transfer.The ideal candidate will have experience working within eng

Spectrum Vision Partners (“SVP”) and OCLI Vision (“OCLI”) work together to provide world class eye care to our patients to improve lives.SVP, the management services team, supports OCLI vision, one of the largest multi-specialty ophthalmology networks in the U.Our unique model and collaborat

Pike Construction Services are looking for Construction Project Managers at all levels to join our growing team.This role is responsible for leading construction projects from start to finish while ensuring strong communication, quality work, and successful project delivery.Our Project Managers play

Senior Highway Project Manager (PE) / Senior Transportation Project Manager.If you've built your career managing construction inspection work — and you're ready for a role with more scope, more influence, and a team that actually invests in its people — this is worth a look.A well-established We

Amazing culture with growing business and teams with a very collaborative environment.Saratoga County, NY - on site role.Domestic freight forwarding operations experience.Working at a freight forwarder, not a manufacturer.Onboard new clients, including oversight of first several shipments as needed.

Senior Project Manager – Construction Management.Long Island, NY (projects across Long Island & NYC).Long Island–based construction management and development firm.Manage project schedules, budgets, and resource planning.Act as the primary liaison for clients, consultants, and key stakeholders.C

Program Manager - Space & Defense .Would you like to be part of a team of technical experts designing unique hardware and embedded software systems to solve complex optical imaging problems? If so, we are looking for someone like you to join the Eoptic team!.At Eoptic, we create cutting-edge imagin

ABOUT K L MASTERS CONSTRCUTION:.K L Masters Construction Company (KLMCC) is widely recognized as one of the Tri-state region’s premier general contractors for large scale residential projects.With a respected track record spanning over two decades, our team has delivered 40 large scale projects on

Engineering Project Coordinator.Are you a highly organized individual with a passion for engineering projects? Our company is seeking a dedicated Engineering Project Coordinator to join our team.As a crucial link between engineering, sales and marketing teams, you will play a pivotal role in facilit

Located in the Westchester / Southern Connecticut Area 5 days a week in office Our client is a fully integrated organization for product development, manufacturing, and distribution within the beauty, skincare, fragrance, and wellness industries.They operate as the operational core behind modern bra

A well-established mechanical contractor based in Suffolk County is seeking a Project Manager / Senior Project Manager to join their team, delivering HVAC and mechanical projects across Long Island and the Queens / Brooklyn / Manhattan corridor.This is an active requirement with a long-standing cont

Rochester, NY (In-person, travel within district required).Rochester, NY market—an already.This is an opportunity to step into a successful market and take it to the next level through leadership, development, and operational excellence.Consistent hours – restaurants close by 9–10 PM.Autonomy

Litigation Administrative Assistant.Insero Talent Solutions has partnered with a growing law firm in search of an Administrative Assistant to support attorneys within its Litigation and Family and Matrimonial Practice Group.This is an excellent opportunity for a seasoned legal administrative profess

Program Manager, IBM Corporation, Armonk, NY and various unanticipated client sites throughout the US (Up to 40% telecommuting permitted): Provide leadership and direction for both program team and business partners.Work cross-functionally to solve problems, implement changes, and ensure appropriate

HUNT is seeking an experienced Architect / Sr.Project Manager to work directly to formulate the architectural design and coordinate the engineering design of education and public projects in communities across Upstate NY and PA.This role will require strong organizational & communication skills.Inte

Colliers Engineering & Design is seeking a dynamic Project Manager to join our Survey/Geospatial group in Rochester, NY.In this role, you’ll lead complex surveying projects that directly support construction and development across the region.We’re looking for a driven professional with a strong