Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
Canton, MA 02021
About the Job
Responsibilities:
- Develop US and EU regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
- Assist in keeping company informed of regulatory requirements in the US and EU.
- Participate on Product Development teams by providing regulatory strategy, timelines, and direction.
- Prepare US and EU submissions. Work with Notified Body and FDA to obtain product approval/clearance. Ensure relevant ISO and FDA requirements are met, as required.
- Review Change Orders and assess regulatory impact of product changes on US and/or EU regulatory strategy and submissions per standard procedures.
- Review labeling, training, promotional and advertising material.
- Support post market regulatory compliance activities for US/EU product approvals.
- Develop and maintain regulatory affairs department procedures and process improvements.
- Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct.
- Assist in keeping company informed of regulatory requirements in the US and EU.
- 5+ years of US/EU medical device regulatory submission experience with Bachelor's degree
- 510(k) or PMA submission experience
- Knowledge of FDA and EU requirements
- Strong communication skills
- Strong technical writing skills
- Regulatory Affairs Certification
- Master's degree in Regulatory Affairs or Engineering
- PMA experience
- IDE experience
Source : Katalyst Healthcares & Life Sciences
