Job Summary
A medical technology company is seeking a Remote Staff Regulatory Affairs Specialist.
Core Responsibilities of this position include:
- Providing strategic input and technical guidance on regulatory requirements
- Assisting in the development and update of regulatory strategy and SOPs
- Providing regulatory input for new product development
Applicants must meet the following qualifications:
- Bachelor’s degree in Engineering, Science, Regulatory or equivalent focus
- 5+ years professional experience
- 3+ years regulatory affairs experience within the medical device or pharmaceutical industry
- General understanding of product development process and design control
- Thorough understanding of FDA and international medical device regulations
- Ability to comply with constantly changing regulatory procedures
