Senior Regulatory Affairs Specialist OrganOx
Overview
Lead and support regulatory activities for devices throughout product lifecycle. Perform impact assessments and prepare submissions for US and international markets. Partner with cross-functional teams to align development with regulatory expectations. Provide training and support to colleagues. Foster process improvements and regulatory intelligence.
What You'll Do9
- 1Lead and support pre-/post-market regulatory activities for assigned devices and projects
- 2Perform regulatory impact assessments for design labelling packaging supplier and manufacturing changes
- 3Prepare compile and coordinate regulatory submissions and change notifications including PMAs and PMA supplements
- 4Support regulatory authority interactions by drafting correspondence and tracking submission progress
- 5Partner with project teams to define regulatory requirements and review supporting documentation
- 6Review verification and validation documentation risk management records and change logs
- 7Contribute to departmental process improvements regulatory intelligence activities and internal tools
- 8Provide training and support to department members
- 9Adhere to OrganOx Code of Conduct and company policies
Requirements8
- 1Strong experience in regulatory affairs within the medical device industry including U.S. Class III devices
- 2Working knowledge of regulatory requirements outside the U.S. including Canada Europe United Kingdom and other jurisdictions
- 3Experience evaluating proposed product changes and determining appropriate regulatory actions
- 4Ability to evaluate standards ISO ASTM and guidance documents for compliance
- 5Excellent verbal communication and technical writing skills
- 6Experience managing multiple priorities and working independently while escalating issues appropriately
- 7Cross-functional collaboration experience with Manufacturing Quality R&D Operations and Clinical
- 8Engagement with regulatory authorities to support submissions and facilitate successful interactions
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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