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Regulatory Affairs Project Manager

Company: Abbott
Location: Santa Clara
Posted on: May 3, 2021

Job Description:

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 109,000 colleagues serve people in more than 160 countries.Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.Our location in Santa Clara CA, currently has an opportunity for a Regulatory Affairs Project Manager. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory and business issues to enable products, including capital equipment and software products, that are developed, manufactured or distributed to meet required legislation. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.**WHAT YOULL DO**Responsible for compliance with applicable Corporate and Divisional Policies and procedures.+ Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes+ Utilize technical regulatory skills to propose strategies on complex issues+ Provide regulatory input to product lifecycle planning+ Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management+ Monitor trade association positions for impact on company products+ Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams+ Premarket- Assess the acceptability of quality, preclinical and clinical documentation for submission filing+ Determine submission and approval requirement and compile, prepare, review and submit regulatory submission to authorities+ Monitor impact of changing regulations on submission strategies and update internal stakeholders+ Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies+ Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval+ Provide strategic input and technical guidance on regulatory requirements to development teams+ Ensure compliance with product post marketing approval requirements+ Actively contribute to the development and functioning of the crisis/issue management program+ Provide regulatory input for product recalls and recall communications+ Provide regulatory input for capital equipment and software, including knowledge of IEC standards (e.g., IEC 60601-1)+ May provide regulatory input on cybersecurity and Artificial Intelligence AI+ May include Medical writing Advertising and promotion Labeling Controlled substances (e.g. DEA) Restricted substances (e.g. REACH, RoHS). Compendial / standards Import / export Country-specific regulatory support+ Effectively communicate both internally and externally with various regulatory agencies.+ May lead a cross-functional or cross-divisional project team+ Act as a mentor to less-experienced staff.**EDUCATION AND EXPERIENCE YOULL BRING****Required**+ Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.+ M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).+ 4-5 years of experience in a regulated industry (e.g., medical products, nutritionals).+ 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.**WHAT WE OFFER**At Abbott, you can have a good job that can grow into a great career. We offer:+ **Training and career development** , with onboarding programs for new employees and tuition assistance+ **Financial security** through competitive compensation, incentives and retirement plans+ **Health care and well-being programs** including medical, dental, vision, wellness and occupational health programs+ **Paid time off**+ **401(k)** retirement savings with a generous company match+ **The stability of a company** with a record of strong financial performance and history of being actively involved in local communities**Learn more about our benefits that add real value to your life to help you live fully:** ( your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.An Equal Opportunity EmployerAbbot welcomes and encourages diversity in our workforce.We provide reasonable accommodation to qualified individuals with disabilities.To request accommodation, please call 224-667-4913 or email

Keywords: Abbott, Santa Clara , Regulatory Affairs Project Manager, Other , Santa Clara, California

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