Regulatory Affairs Specialist

Job TitleRegulatory Affairs Specialist

Job Description

The Regulatory Affairs Specialist provides regulatory leadership for DI product lines and is responsible to build and deliver on competitive regulatory strategies. The Regulatory Affairs Specialist works directly with regulatory agencies to achieve best possible outcomes for effective product market clearances. He / She is responsible for the coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, EU Competent Authorities, CFDA, ANVISA, etc) and to recommend strategies for clinical studies and evaluations.

Responsibilities:

  • Is the Regulatory Affairs representative for DI Programs and assists with regulatory issues related to such items as labeling and marketing ideas, prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for the business.
  • Supports the cross functional teams with regulatory guidance during all design control phases of a new product or major changes
  • Is directly responsible for the coordination and preparation of document packages for regulatory submissions to the US, EU and Canada [510(k) Pre-market Notifications, PMAs, Product Reports/Supplements, US Device Listings, GUDID (UDI), Technical Files, Declarations of Conformity, Medical Device Licenses] for all manufacturing sites.
  • Provides guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X & ISO 14155, Canada Medical Device Regulations, etc.

Requirements:

  • Bachelor's degree in a technical / healthcare / business discipline or equivalent.
  • 3-5 years of relevant experience in a medical device company (FDA Class I or II equivalent – Class III a plus).
  • 3-5 years of experience with successful preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide.
  • Strong working knowledge of medical device regulations (21CFR) and FDA law. Excellent English skills (written and oral).

Desired Qualifications:

  • Certified regulatory affairs professional would be desirable.
  • Experienced in design control process.
  • Experience in supporting international registrations desirable

Contact

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