Regulatory Affairs Specialist (RA/QA) – Medical Devices

About Rimed

Rimed Ltd. is an established medical device company, successfully operating for over 40 years. We specialize in the development and manufacturing of transcranial Doppler (TCD) systems – an advanced technology for non-invasive detection of stenosis in the brain's main arteries. Our systems are sold to stroke-specialized neurologists in more than 50 countries, primarily through a global distributor network.

Rimed is headquartered in Ra’anana, Israel, and operates a U.S. subsidiary in New York.

We are seeking an experienced Regulatory Affairs and Quality Assurance (RA/QA) Specialist to take full ownership of our RA/QA activities. This is a hands-on role for someone who will lead RA/QA as a one-person team - independent, yet collaborative within a small and focused company environment.

Key Responsibilities

·      Take proactive ownership of regulatory and quality activities, including building or refining processes to ensure compliance and audit readiness

·      Prepare and submit FDA 510(k) files and maintain related regulatory documentation

·      Plan and manage ISO13485 audits

·      Support product updates and ensure continued compliance with applicable regulations

·      Lead and/or renew international regulatory approvals, including: China NMPA, Brazil ANVISA, CE MDR (future launch expected)

·      Serve as the point of contact for external consultants, auditors and regulatory agencies

Requirements

·      At least 5 years of hands-on experience in Regulatory Affairs for capital medical device companies

·      Proven experience preparing and supporting FDA 510(k) submissions

·      Proven experience in maintaining the ISO13485 system & supporting audits, with the ability to coordinate and lead audits independently

·      Strong working knowledge of global regulatory standards

·      Ability to work independently and take responsibility for RA/QA activities

·      Team player, proactive with strong communication skills

·      Fluent in English (spoken and written)

Advantages

·      Experience with China NMPA registration is a significant advantage

·      Experience with Brazil ANVISA registration preferred

·      Familiarity with CE MDR requirements preferred

Please send your CV to [email protected]