Key Responsibilities:
Develop and execute global regulatory strategies for new and existing medical products.
Prepare, compile and submit regulatory submissions.
Maintain and update regulatory documentation throughout the product lifecycle, including renewals, changes and post-market surveillance reports.
Serve as the point of contact for communications with regulatory authorities.
Monitor changes in global regulatory requirements and communicate relevant updates to internal teams.
Support internal and external audits, inspections and quality system compliance related to regulatory aspects.
Review and approve product labeling, instructions for use (IFU) and promotional materials for regulatory compliance.
Partner with R&D, Clinical, Quality and Marketing to align regulatory activities with business goals.
Lead or support risk assessments and gap analyses for product compliance.