Remote Regulatory Affairs Manager

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Regulatory Affairs Specialist - REMOTE. This role is crucial for representing the Regulatory Affairs function within project teams, effectively leading regulatory projects to align with corporate objectives. The individual will develop and implement regulatory strategies that support business goals while ensuring compliance with medical device regulations. Collaboration with international partners and internal teams is essential to evaluate marketing authorization pathways and ensure project success. This position also involves mentoring junior team members, influencing product compliance, and handling regulatory challenges in a dynamic environment.

Accountabilities

• Represent the Regulatory Affairs department in project meetings.
• Evaluate marketing authorization pathways with minimal oversight.
• Assess product and manufacturing chan...