Senior Regulator Affairs Specialist

Texas | Quality Assurance / Safety
  • Texas

Senior Regulatory Affairs Specialist

 

Our client, while laser focused in their market, is in a segment where growth is constant and opportunity teems.   Their products are implantable and cover a wide swatch of their surgical specialty but they also have a well-defined pipeline with further opportunity for growth.  The line includes both devices and biologics so any experience you can bring in the latter will be highly valued while your experience in the former is required.

 

Their current focus is domestic so your knowledge, and experience in all things FDA is critical.  You may author submissions but will certainly have responsibility for the breadth of regulatory documents from pre-submission to concept to approval to commercialization.  As the sole proprietor of regulatory you will interact cross-functionally from the shop floor to the executive suite.  This role is filled with challenge but the reward to your personal growth will be astounding.  Should we talk?

 

RESPONSIBILITIES: 

  • Supports marketing, R&D, and operations in regulatory assessment of new, and proposed change to existing products
  • Regulatory representative to all development teams whether for NPD or product update/improvement
  • Authors regulatory documentation for submissions/approvals with notified bodies
  • Champions the company as its representative with reviewers (e.g. FDA) ensuring a sound regulatory strategy for new products and managing the follow-up of submissions under review
  • Interprets regulatory requirements as applicable to the company’s portfolio and procedures; (re-)aligns internal training as needed to address those requirements
  • Takes a lead chair during audits by FDA or other government agencies
  • Ensures that all product listings and registrations are current and meet the regulations
  • Stays abreast of the regulatory landscape monitoring publications both domestic and international for their impact on the company’s products and systems
  • Interacts closely with engineering, quality and legal to ensure IP and Patent opportunities are rationalized

REQUIREMENTS:

  1. BS in Engineering or other Technical or Scientific Discipline
  2. Minimum of 3 (prefer 5) years in a medical device regulatory role
  3. In-Depth familiarity with ISO 13485 and 21 CFR 820
  4. Knowledgeable of EU/CE, MDALL, COFEPRIS, PMDA and other regulatory bodies
  5. Experience in the appropriate interpretation of regulation and (re-)training of staff
  6. 510(k) submissions/approval experience
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