Role Overview:
The Regulatory Affairs Specialist ensures compliance with global regulatory standards (including 21 CFR Part 820, ISO 13485:2016, and GMP) across the full product lifecycle—from development to post-market. This role supports product registration, audits, risk management, and documentation for regulatory filings and inspections.
Key Responsibilities:
- Provide regulatory guidance for new product development to ensure compliance.
- Prepare and submit regulatory documentation (e.g., FDA submissions, Drug Master Files, registrations, renewals).
- Support internal and external audits (FDA, Notified Body, customer, supplier).
- Ensure labeling, packaging, and marketing materials meet regulatory standards.
- Conduct internal audits and maintain audit systems.
- Monitor and interpret regulatory changes and advise cross-functional teams.
- Participate in risk management, design controls, CAPA, and change control processes.
- Maintain and manage regulatory documentation and databases.
- Review Quality Agreements and assist in regulatory gap assessments.
Qualifications:
Education:
- Bachelor's degree (required)
Certifications:
- Auditor training (required)
- Lead Auditor and/or RAC/RCC certification (preferred)
Experience:
- 3+ years in regulatory affairs within medical device or pharmaceutical manufacturing
- Strong knowledge of 21 CFR Part 820, ISO 13485:2016
- Familiarity with 21 CFR Part 210/211, EU MDR, REACH, MDSAP (preferred)
- Experience with audits, GMP, and risk management
Technical Skills:
- Proficient in Microsoft Office, document management systems
- Preferred experience with ERP (e.g., SAP) and electronic QMS systems
Ideal Candidate:
A detail-oriented, highly organized regulatory professional with strong communication and cross-functional collaboration skills, experienced in audits and global compliance standards, and capable of managing multiple regulatory projects in a fast-paced setting.
Job sourced from Polysciences, Inc. / Kyfora Bio LLC.