KH
Integration Sr. Project Manager
Katalyst Healthcares & Life Sciences
🇺🇸 United States
Remote
Manager or above
1 month ago
1 month ago
A medical device company in Texas is seeking a contractor to provide product life cycle support for a Class III medical device while covering a medical leave. The ideal candidate will be based in Texas, but we will also consider qualified candidates outside the area if they are a strong fit and within budget. Responsibilities:
- Provide strategic regulatory guidance and support integration activities related to a newly acquired entity.
- Represent the Regulatory Affairs function during integration and implementation activities.
- Help define and draft procedures as needed, including claims review and approval.
- Author internal regulatory documentation in accordance with established requirements and procedures.
- Assess product and process changes and complete regulatory impact assessments.
- Support PMA, MDR, and MDD file maintenance for high risk products.
- Ensure compliance with internal procedures and applicable regulations.
- Support internal processes to maintain compliance with agency approvals.
- Collaborate with international personnel and external consultants to deliver against the project plan.
- Support international registrations and renewals as needed.
Integration Sr. Project Manager · Katalyst Healthcares & Life Sciences