Regulatory affairs Specialist (RA/QA ) JB-4589

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

Maintain ISO13485/QMS system & prepare for 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

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)