Interim Integration Sr. Project Manager

Job Description: 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. #J-18808-Ljbffr Gofractional