Integration Sr Project Manager

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.

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, Pharmacy, Medical Technology, Engineering, or a related field.
• Strong experience in Medical Device Regulatory Affairs.
• Experience supporting Class III medical devices and high-risk products.
• Knowledge of PMA, MDR, and MDD regulatory requirements.
• Experience with product lifecycle management and regulatory compliance.
• Experience performing regulatory impact assessments for product and process changes.
• Experience maintaining regulatory files and supporting agency approvals.
• Strong understanding of medical device regulations and quality requirements.
• Experience supporting international registrations and renewals.
• Strong project management, organizational, and stakeholder management skills.
• Excellent written and verbal communication skills.
• Ability to collaborate with international teams, external consultants, Quality, Engineering, and Regulatory Affairs.
• Strong technical writing and regulatory documentation skills.
• Ability to manage multiple priorities and deliver projects within established timelines.
• PMP or RAC certification is a plus.
• 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.