Director Regulatory Affairs Cardiac

Profile

Director, Regulatory Affairs, Cardiac
The candidate will provides division-wide regulatory direction for product development and support to develop most rapid successful strategy for approval to market products to meet business objectives; administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions; attract and develop superior regulatory professionals and regulatory competencies. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Develop and advance the organization’s policy and procedures for regulatory affairs and compliance to establish a compliant culture. Anticipate regulatory and related obstacles and emerging issues throughout the product life-cycle. Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions. Develop global regulatory strategies and update based upon regulatory change. Develops, communicates, and builds consensus for operating goals that are in alignment with the division and corporation. Interfaces with a variety of management levels including senior management on significant matters, often requiring the coordination of activity across organizational units. Bachelor’s Degree (+ 16 years) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. MS in a technical area or MBA is preferred; a PhD in technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). 7-10 years of experience in a regulated industry required, for example medical devices, diagnostics, nutritionals; experience in in-vitro diagnostics (IVD) strongly preferred.

Company info

Sign Up Now - EmploymentCrossing.com