Careers

Regulatory Affairs Manager

Duties & Responsibilities

  • Lead the development and implementation of regulatory strategy for all business units of the company.
  • Prepare and coordinate regulatory submissions (e.g., ISO, FDA, CE, safety reports, 510 (k), Technical files, Amar approvals, etc.) in accordance with applicable regulations.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate procedures.
  • Assisting various departments in the organization, such as R&D and
  • Marketing, from regulatory aspects. Starting from product definition to release.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

 

Demands

  • Requires a Bachelor’s or Master’s Degree in scientific discipline (Ph.d a plus)
  • Minimum of 3 years of experience in medical device sector
  • Deep understanding of all regulatory affairs aspects related to medical devices, quality process, including standards, methods, and procedures
  • Experience with Class II/III medical devices
  • Experience with ISO 13485, and Council Directive 93/42/EEC
  • Solid organizational, analytical, and problem solving skills
  • Sound communication skills (both verbal & writing)
  • Excellent interpersonal skills, team player
  • English – very high level – a must
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