Regulatory Affairs Project Manager - Vascular (on-site)

Abbott Laboratories • Westford, MA

13d • $99,300 - $198,700 • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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

Responsibilities

• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior