Strategic Regulatory Affairs Leader for Medical Devices

Regulatory Jobs; Westford (MA); Vor Ort; USD 129.000 - 259.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement plan

Tuition reimbursement

Freeeducation benefit

Zusammenfassung

Abbott is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy and submissions for vascular products. This on-site role at our Westford, MA location requires directing a team of regulatory professionals and interfacing with FDA and international agencies to ensure timely approvals.

The position emphasizes governance of regulatory data, development of guidance for product development teams, and ongoing liaison with senior management on regulatory plans.

Qualifikationen

• Bachelor’s degree or equivalent required.
• 5–7 years’ experience in a regulated industry (e.g., medical products).
• Experience in regulatory preferred but may consider related areas.

Aufgaben

• Sets strategy and directs submissions for products to regulatory agencies.
• Guides regulatory requirements and strategies to product development teams.
• Maintains knowledge of laws, regulations and enforcement decisions affecting operations.
• Directs staff in implementing regulatory strategy and preparing submissions.
• Interacts with outside regulatory agencies and provides executive metrics.

Kenntnisse

Regulatory affairs

Leadership

Regulatory strategy

Regulatory submissions

Ausbildung

Bachelor’s degree

MS or MBA preferred

Jobbeschreibung

Abbott is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy and submissions for vascular products. This on-site role at our Westford, MA location requires directing a team of regulatory professionals and interfacing with FDA and international agencies to ensure timely approvals.

The position emphasizes governance of regulatory data, development of guidance for product development teams, and ongoing liaison with senior management on regulatory plans.