Regulatory Affairs Project Manager - Vascular - Full-time

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
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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

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 Westford MA, 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. This new team member 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 as well as identify data needed, obtain this data and ensure that they are effectively presented for the registration of products worldwide.

WHAT YOU’LL DO

• Provide regulatory input to product lifecycle planning
• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes
• Assist in regulatory due diligence for potential and new acquisitions
• Utilize technical regulatory skills to propose strategies on complex issues
• 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.
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing
• Determine submission and approval requirements and compile, prepare, review and submit regulatory submissions 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)
• Provide regulatory input on cybersecurity and Artificial Intelligence (AI)
• Job specific responsibilities 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.
• Provides leadership by communicating and providing guidance towards achieving department objectives.
• Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
• May lead a cross-functional or cross-divisional project team.
• Acts as a mentor to less-experienced staff.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Required Qualifications

• Bachelor's Degree
• 4-5 years of experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience.
• 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with various regulatory agencies.
• Ability to work effectively on cross-functional teams.
• Pay strong attention to detail.
• Organize and track complex information.
• Exercise good and ethical judgment within policy and regulations
• Use in-depth knowledge of business functions and cross group dependencies/ relationships.
• 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
• M.S. in a technical area or M.B.A. A Ph.D. in a technical area or law is helpful.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
• Previous experience with 510k / PMA submissions
• Experience working with hardware/ software devices
• Familiarity with Predetermined Change Control Plans (PCCPs)
• Experience with Medical Devices
• Must be able to juggle multiple and competing priorities
• Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
• Has a sound knowledge of a variety of alternatives and their impact on the business

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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.

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The base pay for this position is $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.