Mar 07, 2019

ASSOCIATE DIRECTOR REGULATORY AFFAIRS, ABBOTT POINT-OF-CARE (APOC)

  • Abbott
  • Princeton, NJ, USA
Full time Regulatory

Job Description

This position entails management of submissions to regulatory bodies, requiring working knowledge of products under review and of relevant regulations. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with the international sales organizations, international regulatory bodies, and in-house personnel.. Experience should demonstrate dependability, flexibility and maturity.

 PRIMARY RESPONSIBILITIES

  • Responsible for compliance with applicable Corporate and Divisional Policies and procedures.Manage the APOC International Regulatory team. Team is responsible for supporting affiliates and distributors in registering products by preparing and filing documentation as required for international regulatory registrations, responding to any questions, and achieving timely regulatory clearance/approval for marketing.
  • Monitor regulatory intelligence and identify and communicate changes impacting APOC.
  • Develop Regulatory team expertise in project management and product knowledge, and maintain staffing needs to support all current and near term international filings.
  • Create optimized regulatory strategies for international registration to support business goals and approval to ensure most efficient approval times.
  • Review design changes for International Regulatory.
  • Assist in review of international product labeling and marketing materials.
  • Assist in development of relevant regulatory SOPs and training staff as necessary
  • Ensure conformance to local country and EU regulations.
  • Assist with other regulatory matters as requested.

MINIMUM QUALIFICATIONS

Bachelor's degree (or equivalent); 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.)   5-7 years experience in a regulated industry (e.g., medical products, nutritionals). 5-7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 

DESIRED QUALIFICATIONS:

  • Bachelor’s degree in a life science field
  • 8 years experience in the medical device industry, or equivalent
  • 5 years experience in a regulatory capacity within the medical device industry. IVD experience is a plus
  • Demonstrated experience in intentional regulatory filing 
  • Job Breakdown

    Job Breakdown

  • 30911191

  • Regulatory Operations

  • APOC Point of Care

  • Princeton, New Jersey, United States of America

  • Yes, 20 % of the Time

  • No

  • Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)


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