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Job Description
Regulatory Affairs Specialist: Develop and implement regulatory strategies to bring medical devices to market and ensure ongoing compliance.
The Regulatory Affairs Specialist works closely under direct supervision to learn and develop the regulatory skills required to bring medical devices to market and ensure ongoing compliance. Key responsibilities include:
- Participating on cross-functional teams to develop global regulatory strategies
- Authoring regulatory submissions and interacting with regulatory agencies/notified bodies
- Reviewing labeling and marketing materials for compliance with regulatory requirements
- Evaluating proposed device changes and assessing global impact
- Contribute towards obtaining US and EU regulatory approvals by authoring, compiling, and submitting premarket regulatory applications
- Partnering with global regulatory affiliates to provide submission documentation for expedited international market access and sustaining support
- Reviewing and approving change documentation for regulatory impact on launched products
- Providing regulatory input for and appropriate follow-up to inspections and audits
- Reviewing and approving labeling, advertising and promotional items for compliance before release
- Assisting in the development, implementation, and maintenance of regulatory procedures to ensure ongoing compliance of new and existing products
- Preparing and updating US product registrations and listings
- Assisting in the establishment and maintenance of regulatory information systems
- Participating in process improvement activities and projects
- Assisting in complex projects and performing delegated tasks as required
- Assisting with product post-market or clearance requirements
- Assessing the acceptability of quality, preclinical and clinical documentation for submission to comply with regulatory requirements
- Identifying issues early in the submission preparation process that could impact product launch
- Communicating and negotiating with regulatory authorities and stakeholders under supervision of more experienced RA team-members
- Ensuring project team(s) and RA management remain informed regarding all regulatory agency/Notified Body correspondence
Minimum Requirements:
- Bachelor's degree in an Engineering, Science, or equivalent field
- 0-2 years in a Regulatory Affairs role