What are the responsibilities and job description for the Regulatory Affairs Specialist position at EnIn Systems?
Responsibilities:
- Prepare and submit regulatory filings (FDA, EMA, MHRA, Health Canada, etc.).
- Ensure compliance with global regulatory standards (FDA 21 CFR, ISO 13485, MDR, etc.).
- Maintain up-to-date knowledge of regulatory requirements and implement changes.
- Collaborate with R&D, Quality Assurance, and Manufacturing teams to support regulatory needs.
- Review and approve labeling, promotional materials, and technical documents.
- Support audits and inspections from regulatory agencies.
- Maintain regulatory documentation and ensure timely updates.
- Provide regulatory strategy guidance for new product development and market expansions.
Required Skills:
- Strong knowledge of FDA, EMA, and global regulatory requirements.
- Experience with regulatory submissions (510(k), PMA, IND, NDA, CE Mark, etc.).
- Understanding of Good Manufacturing Practices (GMP), ISO 13485, and Quality Management Systems (QMS).
- Ability to interpret and apply regulatory guidelines.
- Strong documentation and analytical skills.
- Excellent communication and cross-functional collaboration skills.
Preferred Qualifications:
- Experience in medical devices, pharmaceuticals, or biotechnology industries.
- Familiarity with regulatory software tools.
- Certifications such as RAC (Regulatory Affairs Certification) are a plus.
