Regulatory Affairs Manager
8 days ago
Pacheco
Job Description Our Company Biocare Medical, LLC is an innovator in developing and supplying world class automated immunohistochemistry instrumentation, and the full range of reagents for IHC lab testing. Biocare specializes in high quality IHC, ISH, and FISH slide staining through its brand-new automated instrument, NeoPATH Pro™, and offers best-in-class simultaneous Multiplex IHC solutions. The company's customers include clinical histology laboratories, pharmaceutical companies, CROs, biotechnology companies as well as academic, government, military, and non-profit laboratories. Biocare Medical offers an expanding portfolio of integrated products to address the rapidly growing cancer and infectious disease diagnostic and research markets with novel tissue immunohistochemistry and in situ hybridization methods. Biocare Medical is headquartered and has manufacturing facilities in California with a global distribution network. Summary The Regulatory Affairs Manager is responsible for leading and mentoring Biocare Medical's Regulatory Affairs team, with direct oversight of global regulatory strategy, submissions, and compliance activities. This role focuses on obtaining and maintaining product registrations in key markets including the EU (IVDR), LATAM, Asia, and MDSAP-participating countries, specifically for Biocare's IVD product portfolio, including antibody-based diagnostics. The Senior Manager ensures the development and timely submission of compliant technical documentation, collaborates cross-functionally with R&D and Quality teams, and drives alignment with global regulatory requirements and internal quality standards. This position also supports the implementation and maintenance of an eQMS, and plays a critical role in fostering regulatory excellence, audit readiness, and continuous improvement across the organization. Essential Functions Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Lead, mentor, and manage the Regulatory Affairs (RA) team, including performance reviews, workload planning, and professional development., • Develop and implement global regulatory strategies for new and existing IVD products (Class A to D/Class I to III), including antibodies and diagnostic systems, in key markets (EU, LATAM, Asia, MDSAP-participating countries)., • Act as the primary RA liaison for product submissions and regulatory strategy across LATAM, the EU (IVDR), MDSAP-participating countries, and Asia., • Oversee preparation, submission, and maintenance of regulatory documentation, including CE Mark, Health Canada, ANVISA, NMPA, MFDS, and other country-specific filings., • Write and manage compliant technical documentation (LATAM, the EU (IVDR), MDSAP-participating countries, and Asia) and ensure timely internal review and approval., • Collaborate closely with R&D to embed regulatory requirements throughout the product design and development lifecycle., • Provide strategic regulatory input and serve as the company representative in interactions with regulatory agencies and notified bodies., • Review and approve technical file deliverables (e.g., validation protocols, V&V reports, PMS reports, literature reviews) to ensure compliance with IVDR and other global requirements., • Ensure timely development and delivery of high-quality regulatory documents, including GSPRs, gap assessments, risk management documentation, and post-marketing surveillance reports., • Deliver internal training on global regulatory requirements, with a strong emphasis on IVDR., • Leverage eQMS experience to support implementation and ensure ongoing regulatory compliance, system integrity, and alignment with global quality standards., • Develop and maintain regulatory SOPs, guidance documents, and templates; lead and deliver company-wide and RA team-specific compliance and regulatory training., • Support the compliance and CAPA team., • Identify and implement process improvements to enhance department efficiency, documentation quality, and regulatory compliance., • Track and report on the status of regulatory deliverables to senior management; participate in management reviews., • Support external audits and inspections by coordinating with notified bodies and internal teams., • Update existing legacy technical files to ensure compliance with IVDR requirements, including format, content, and risk documentation., • Maintain up-to-date knowledge of global regulatory requirements, industry trends, and evolving standards., • Serves as the designated PRRC under the EU IVDR, ensuring the company's full compliance with all applicable regulatory requirements throughout the product lifecycle, including review of technical documentation, vigilance activities, and acting as the primary liaison with regulatory authorities., • Promote a culture of regulatory excellence and continuous improvement across the organization., • Support internal and external audits and inspections by regulatory authorities and notified bodies; prepare documentation and coordinate responses to audit findings, • Oversee coordination with external regulatory consultants and local agents for international submissions; lead planning and management of the regulatory affairs budget, ensuring alignment with project priorities and organizational goals., • Bachelor's degree or equivalent experience., • A minimum of five (5+) years working in regulated medical device/IVD or related industry., • A minimum two (2+) years of management experience required., • Strong knowledge of international submissions (LATAM, EU, Asia and MDSAP countries)., • Experience with antibody-based diagnostics is strongly preferred., • Excellent leadership, communication, and project management skills., • Familiarity with eQMS (MasterControl, Veeva Vault, AssurX) is highly desirable., • Expert knowledge of the compliance requirements of IVD Regulation 2017/746, NMPA, MFDS, AMDD, etc., • Knowledge of compliance with harmonized international standards and regulations relevant to IVD devices such as ISO 13485:2016, ISO 14971:2019, MDSAP, • Demonstrates strong analytical, critical thinking, problem solving and investigative skills., • Excellent interpersonal skills and the ability to work collaboratively with the wider team., • Excellent organizational skills, attention to detail and an ability to work to tight timelines under minimum supervision., • Excellent oral and written communication skills., • Experience with eQMS (MasterControl, AssurX, Veeva Vault QMS)., • Onsite - Pacheco, CA, • Company Sponsored Health Insurance - Medical, Dental, Vision, • Company Sponsored Life Insurance, • Voluntary Benefits, • Retirement plan with a match - 401(k), • PTO, • Paid Holidays All inquiries strictly confidential.
Cleaning
Driver & Delivery
Chef & Cook
Waiters
Construction & Trades
Security
Fast Food
Salon & Beauty
Office & Admin
Retail
Sales & Marketing
Warehouse
Customer Service
Host & Hostess
Barista
Entertainment
Accounting & Finance
Animal Care
Art, Media, Design
Bar Staff
Child Care
Education
Engineering
Events & Promotion
Fashion
Healthcare
Information Technology
Legal
Management
Manufacturing
Online Jobs
Science
Sports & Wellness
Writing & Editing
Other