Become a pivotal member of Medtronic as a Regulatory Affairs Specialist. Focus on ensuring compliance and accelerating approvals for cutting-edge medical devices. You will lead the preparation of regulatory submissions and engage with agencies to facilitate timely approvals.
This role involves collaboration with various experts to navigate challenges and recommend compliance strategies. Your efforts will directly impact patient care by ensuring that high-quality products meet regulatory standards. Key Responsibilities:
Coordinate document preparation for regulatory applications
Identify compliance needs for product changes
Collaborate with teams to tackle regulatory inquiries
Conduct audits and maintain systems for regulatory tracking
Foster relationships with regulatory agencies for effective communication Requirements:
Bachelor’s degree required
Minimum of 2 years in regulatory affairs
Experience with Health Canada is a plus
Proficient in project management and analytical tasks
Robust verbal and written communication skills Utilize your regulatory expertise to enhance healthcare impact at Medtronic.