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