Regulatory Affairs Manager

4 days ago


Thousand Oaks, California, United States accordance search group Full time
Job Description
We are seeking a highly skilled Regulatory Specialist to join our team at Accordance Search Group. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with global regulations and guidelines for medical devices.

**Key Responsibilities:**
  • Provide comprehensive regulatory support for new product launches and existing product lines.
  • Develop and implement global regulatory strategies for various devices.
  • Prepare and submit regulatory submissions for US and international markets.
  • Create, review, and approve change requests to ensure compliance with regulatory requirements.
  • Assist in defining regulatory strategies and manage submission activities for complex product development projects.


**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: $80,000 - $110,000 per year**, depending on qualifications and location.

Benefits:
Competitive salary, excellent benefits package, and opportunities for career growth and professional development.

If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply.

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