Regulatory Affairs Project Manager - Vascular (on-site)

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.

     

JOB DESCRIPTION:

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 Freedom 2 Save student debt program and FreeU 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