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.