Regulatory Affairs Leader
This role plays a pivotal part in defining and driving the company's global regulatory strategy, ensuring seamless market access as the business scales rapidly.
* Key Responsibilities:
* Develop and drive strategic regulatory initiatives to support product development, commercialization, and expansion activities.
* Manage all regulatory submissions (CE marking, FDA 510(k)/PMA) and ensure alignment with operational timelines.
* Serve as primary liaison with regulatory authorities, representing the company in all regulatory interactions and negotiations.
* Build and lead a high-performing regulatory team to support product development and market access activities.
* Monitor evolving regulatory requirements to ensure proactive compliance across geographies.
* Collaborate closely with cross-functional teams to integrate regulatory requirements into project plans and strategic decision-making.
* Support partnership activities through regulatory assessments and strategy development.
Key Skills and Qualifications:
* Proven track record in regulatory affairs leadership.
* Excellent communication and stakeholder management skills.
* Ability to work collaboratively across functions.
* Strong analytical and problem-solving skills.
* Knowledge of regulatory frameworks and guidelines.
Benefits:
Opportunities for career growth and professional development.
Others:
Collaborative and dynamic work environment.