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Sr. International Regulatory Affairs Associate
Ref No.: 18-10263
Location: Raritan, New Jersey
8-5
SENIOR INTERNATIONAL REGULATORY AFFAIRS ASSOCIATE

The Senior International Regulatory Affairs Associate will contribute to Company's regulatory strategies and content plans from an international perspective (ex-US), supporting all business fields. The primary responsibility is managing the coordination, compilation and submission of regulatory applications to regulatory agencies worldwide.

RESPONSIBILITIES:
  • Interpret Regulatory requirements and determine strategy to obtain registrations. Helps achieve departmental objectives through work processes.
  • Partner with medical device Market Quality contacts, third parties, and distributors worldwide to develop regulatory strategies, resolve regulatory matters, and submit and maintain product registrations to gain and maintain market access for medical device products defined in the commercial business case.
  • Assist in representing Company to domestic and international regulatory agencies, including Notified Bodies.
  • With management oversight, interact with International regulatory personnel to expedite pending applications, resolve regulatory matters, manage meetings for regulatory submissions.
  • Work independently to identify and obtain data needed to support regional regulatory strategies.
  • Provide guidance to business partners regarding regulatory requirements including indications of risk and approximate timing for approvals for planning purposes.
  • Execute activities related to maintaining compliant regulatory status for marketing products worldwide, including annual reporting, change management/change notifications, labeling review, copy review, etc.
  • Support Regulatory Transition for emerging markets, while supporting global Regulatory Transition strategies.
  • Where applicable, assist in External influence activities with Industry Trade associations, Standardization organizations, etc. to stay abreast and impact policies and standards applicable to the medical device business.
  • Support and/or lead departmental initiative, such as process improvement, as required.
  • Perform other work-related duties as assigned.

QUALIFICATIONS:
A minimum of Bachelor's degree in a Scientific or related discipline is required. Master's Degree is desirable.

Minimum of 4-6 years of experience in a regulated Medical Device Industry required, IVD Industry experience preferred.
A working knowledge of US/EU/WW Regulations, FDA and WW guidance for Medical Devices (IVDs specifically), IVD Directive required.
Experience developing regulatory strategies and an understanding of Product Development is preferred.
Excellent interpersonal, teamwork and verbal/written communication skills are required. Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems simultaneously are required.

Ability to demonstrate model behavior, understand priorities and encourage others to drive for results.

The ability to work with business partners across geographies and time zones is critical.