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.
- 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