Clinical Evaluation - Senior Project Manager – Medical Devices (on-site)
1 month ago
Plano
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: • Career development with an international company where you can grow the career you dream of., • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year., • An excellent retirement savings plan with high employer contribution, • Tuition reimbursement, the ___ student debt program and ___ education benefit - an affordable and convenient path to getting a bachelor’s degree., • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune., • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. The Opportunity Our location in Plano, TX, Austin, TX, Santa Clara, CA, Sylmar CA or Maple Grove, MN currently has an opportunity for a Clinical Evaluation - Senior Project Manager. This new team member will combine understanding of scientific and research methodology, medical device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, MDCG Guidance documents, and EU MDR 2017/745. This role will support the Neuromodulation product lines. What You’ll Work On • Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports and associated documents; set deliverable and project timelines and ensure timelines are met., • Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers)., • Review, edit, and write portions, as needed, of Clinical Evaluation Reports and associated documents., • Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions., • Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development teams and sustaining teams., • Compliance with applicable corporate and divisional policies and procedures., • Participate in and support internal and external audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics., • Develop and update new policies, as appropriate, for processes and procedures relating to the clinical evaluation process, and train key personnel on them., • Function independently as a decision-maker on CER-related regulatory issues. Required Qualifications • Bachelor’s Degree, • Minimum 2 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area., • Minimum 3 years of experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience., • Principles and requirements of applicable product laws, • Ethical guidelines of the regulatory profession, clinical research and regulatory process, • Create and manage project plans and timelines, • Think analytically, pay strong attention to detail, organize and track complex information, • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results, • Follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues. Preferred Qualifications • Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields., • Advanced degree, • Scientific/research background; training and degree in science, engineering, or medical fields; understanding of research design, methodology, and statistics., • Thorough understanding of the EU MDR 2017/745, MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev 4, MDCG Guidances on clinical evaluations, SSCP, PMCF plans and reports, and other international harmonized standards and guidelines related to medical devices, clinical studies, and quality systems., • Project management and/or management of people experience., • Strong presentation skills in relevant areas of clinical/technical applications., • Strong command of medical and surgical terminology., • Demonstrated ability to identify and adapt to shifting priorities and competing demands., • Highly developed interpersonal skills, and strong attention to detail., • 5-7+ years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry., • 3-5+ years of experience writing, reviewing or leading development of CERs and related documents in accordance with MEDDEV 2.7/1 Rev 3 and 4, the medical device directives (MDD 93/42/EEC; AIMDD 90/385/EEC) and the EU MDR 2017/745., • Certification is a plus (e.g., RAC and PMP). Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ___ Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at ___, on Facebook at ___ and on Twitter @AbbottNews. The base pay for this position is $75,300.00 – $150,700.00. In specific locations, the pay range may vary from the range posted.
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