דרושים Regulatory Affairs and Quality Assurance Specialist ברעננה

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 |** לפנייה למשרה יש להגיש מועמדות **|