Associate Director Regulatory Affairs – Vascular (on-site)

• 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

• 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.

• Sets strategy and directs preparation of submissions for products to regulatory agencies, and interfaces with agencies in order to obtain timely approval to produce and market new products.
• Provides guidance on regulatory requirements and strategies to product development project teams.
• Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders.
• Consults with and provides advice to senior management of the Company on strategies and plans for regulatory product approvals.
• Directs staff in implementing regulatory strategy and preparing regulatory submissions.
• Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.
• Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
• Performs related functions and responsibilities, on occasion, as assigned.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communication.

• Bachelor’s Degree or an equivalent combination of education and work experience
• 5-7 years’ experience in a regulated industry (e.g., medical products, nutritionals).
• 5-7 years’ experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.

• 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.)
• Experience with U.S. Food and Drug Administration (FDA) Class III/II device regulations and EU MDR regulations.
• Prior experience managing and coaching a team.

• 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.

Abbott