Medical Device Regulatory Specialist
3 days ago
Accordance Search Group is a leading provider of recruitment services for the medical device industry. We are seeking a highly skilled Regulatory Specialist to join our team and support our clients' needs in regulatory affairs.
**Responsibilities:**
- Collaborate with cross-functional teams to provide comprehensive regulatory support.
- Prepare and submit regulatory submissions for US and international markets.
- Develop and implement global regulatory strategies for various devices.
- Review and approve change requests to ensure compliance with regulatory requirements.
**Requirements:**
- Bachelor's degree in Biomedical Engineering, Biotechnology, Regulatory Sciences, or related field.
- 3-5 years of experience in International Regulatory Affairs, preferably in the Medical Device industry.
- Familiarity with 21 CFR 820, ISO 13485, and European Medical Device Regulation 2017/745.
**Estimated Salary: $90,000 - $120,000 per year**, depending on qualifications and location.
Job Requirements:
B.S. degree in relevant field, 3-5 years of experience in international regulatory affairs, familiarity with key regulations and standards.
**Why Choose Us:**
Competitive salary, excellent benefits package, and opportunities for career growth and professional development.
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