Job Title: Regulatory Compliance Specialist
About the Role:
We are seeking a seasoned Regulatory Affairs professional to support our business growth in the medical device industry.
The ideal candidate will have at least 7 years of experience in regulatory affairs, with a strong background in FDA submissions and regulations.
Key Responsibilities:
* Develop and implement regulatory strategies for FDA submissions as part of cross-functional teams.
* Collaborate with R&D, Clinical, and Medical teams to coordinate the preparation of FDA applications and responses to FDA questions.
* Represent Regulatory SME in Design Control documentation review.
* Coordinate the preparation of regulatory submissions (such as IDE, original PMA, and supplements) in accordance with FDA requirements.
* Assess the regulatory impact of proposed product and process changes according to FDA requirements.
* Review product labeling and marketing material for compliance with FDA regulations.
* Participate in audits and inspections, ensuring compliance with FDA requirements.
* Stay up-to-date with relevant regulations, guidelines, and industry trends, providing gap and impact assessments on new or updated FDA regulations.
* Maintain accurate databases and regulatory documentation, including FDA establishment registration and device listing.
* Ensure timely updates of regulatory SOPs.