法規經理 Regulatory Affairs Manager

醫材/醫療器材/生技 產業

Key Responsibilities
1. Develop regulatory strategies for new and existing products.
2. Lead global regulatory submissions and approvals.
3. Monitor regulatory changes and assess business impact.
4. Review design changes and determine regulatory implications.
5. Support audits and inspections by regulatory authorities and notified bodies.
6. Maintain regulatory documentation and product registrations.
7. Provide regulatory guidance throughout the product lifecycle.
8. Manage external regulatory consultants and agency interactions.

Leadership Competencies
1. Ability to lead and develop RA team members.
2. Strong project management skills.
3. Experience working with cross-functional teams including R&D, Quality, PM,
Manufacturing, and BD.
4. Ability to communicate regulatory requirements to senior management.

Preferred Qualifications
1. Experience with Class II or Class III medical devices.
2. Knowledge of UDI, cybersecurity requirements, and clinical evaluation
requirements.
3. Experience supporting international market expansion.

Submission Experience
Experience preparing and managing:
1. 510(k), EU MDD/MDR, submissions preferred
2. Technical Documentation /Technical Files
3. Design Dossiers
4. Product registrations and renewals
5. Change notifications and regulatory impact assessments