Regulatory Affairs Specialist
Company: Katalyst Healthcares & Life Sciences
Posted on: May 28, 2023
- Acts as a core team member on sustaining and new product
development projects, providing regulatory feedback and guidance
throughout the product development cycle.
- Develops and executes regulatory strategies for new and
- Works with regulatory and cross-functional peers to resolve
potential regulatory/technical issues and questions from the
- Manages the release and shipment of products under regulatory
controls to all regions.
- Provides recommendations for how to overcome regulatory
barriers and resolve any disputes within teams as to the importance
of regulatory requirements.
- Coordinates and prepares regulatory submissions for new and
modified products ensuring compliance with applicable regulatory
requirements and company policies.
- Handles the preparation and processing of documentation
required for new product introductions and revised products in
- Reviews and approves design and manufacturing changes for
existing products, ensuring compliance with applicable
- Provides technical guidance and regulatory training to
- Reviews device labeling and advertising materials for
compliance with applicable regulations and recommends appropriate
- Monitor the development of new regulatory requirements and
advise of the impact to cross-functional teams.
- Develops and maintains procedures to ensure compliance and
support business goals.
- Maintains proficiency in government regulations and
- Support other regulatory requests or projects as needed.
- Bachelor's degree with a minimum of 2 years of medical device
- Prior experience with regulatory submissions, such as PMA or
- Working knowledge of FDA and international regulations for
- General understanding of the product development process and
- Ability to manage several projects simultaneously.
- Strong interpersonal and influencing skills.
- Ability to independently manage projects, prioritize time and
Keywords: Katalyst Healthcares & Life Sciences, Clifton , Regulatory Affairs Specialist, Other , Clifton, New Jersey
Didn't find what you're looking for? Search again!
Loading more jobs...