Note: The job is a remote job and is open to candidates in USA. Planet Pharma is seeking a contractor to provide product life cycle support for a Class III medical device while covering a medical leave. The Integration Senior Project Manager will provide regulatory guidance, support integration activities for a newly acquired entity, maintain regulatory files, assess product and process changes, and help ensure compliance with applicable regulations and agency approvals.
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
Skills
- 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
Company Overview