A innovative medical device company is seeking a highly experienced Director of Regulatory Affairs to join their team in Minnesota. The successful candidate will be responsible for leading, developing and implementing all global regulatory strategy. The role requires a driven individual with excellent leadership skills and ability to work in a collaborative cross-functional team environment.
Responsibilities
- Develop and implement regulatory strategies that align with the company's goals and objectives.
- Ensure compliance with all regulatory requirements and stay up to date on the changing regulatory environment.
- Lead the regulatory team and provide guidance and mentorship to team members.
- Manage all regulatory submissions and approvals.
- Develop and maintain relationships with regulatory authorities.
- Provide leadership and guidance to cross-functional teams.
Skills
- Strong leadership and people management skills.
- Ability to develop and implement regulatory strategies.
- Excellent communication and interpersonal skills.
- Ability to work collaboratively with cross-functional teams.
- Strong analytical and problem-solving skills.
Qualifications
- Bachelor's degree in a relevant field.
- 7+ years of experience in regulatory affairs.
- Pharmaceutical experience, specifically with Biologic products, is strongly preferred.
- Experience working directly with Health Authorities.
