As a Regulatory Affairs Specialist - ET at Medtronic, you will play a crucial role in ensuring the regulatory compliance of our medical devices throughout their design and development lifecycle. You'll work collaboratively within a dynamic team, providing essential regulatory guidance, preparing global registration documents, and meticulously reviewing technical data to support marketing authorizations. Your expertise will directly contribute to Medtronic's mission of expanding healthcare access globally.
A Day in the Life
You will ensure regulatory excellence and compliance by:
- Supporting Design and Development Control activities with regulatory requirements, direction, tactics, and strategies.
- Preparing, reviewing, filing, and supporting premarket documents for global registrations for assigned projects.
- Collaborating with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
- Reviewing pre-clinical and clinical protocols and associated reports to be used in submissions for assigned projects.
- Developing regulatory strategies for new or modified products for assigned projects.
- Monitoring and providing information pertaining to the impact of changes in the regulatory environment.
- Documenting, consolidating, and maintaining oral and written communication with health authorities.
- Preparing internal documents for modifications to devices, when appropriate.
- Participating in health agency inspections & notified body audits as necessary.
- Authoring and/or reviewing regulatory procedures and updating as necessary.
- Reviewing change control documents and ascertaining regulatory impact for external and internal documents through formal regulatory assessments.
- Assisting in the development/maintenance of regulatory files, records, and reporting systems for systematic retrieval of information.
- Reviewing promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.
- Ensuring compliance to regulations specific to clearance and approvals of MEIC developed product's raw material and/or prototype.
Required Knowledge and Experience
- Bachelor's degree in Medical, Mechanical, Electrical, Life Science, or other healthcare-related majors.
- 4-7 years of experience in a Regulatory Affairs role within the medical device and/or pharmaceutical industry.
- Good understanding of regulations and policies issued by India, US FDA, and EU, with the ability to interpret international regulatory requirements.
- Excellent written, organizational, and communication skills are required.
- Possesses a flexible and team-oriented attitude.
- Strong attention to detail and ability to handle multiple tasks.
- Proficient in planning and capable of working under pressure.
- Good at English, including reading, writing, and speaking.
- Demonstrates a good learning attitude.
Nice to Haves
- US and global regulatory affairs knowledge and experience.
- Experience working with cross-functional teams.
- Effective verbal and written communication skills both internally and externally.
- Experience with solving problems and concerns.
- Experience with project management and adherence to time schedules.
- Ability to work well under pressure in a dynamic environment.
- Highly organized, detail-oriented, and efficient.
- A team player who seeks to help and learn from colleagues, seeing department success as their own.
- Ability to manage projects to completion within and outside of the direct department and company.
- Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism.
- Proactively seeks to develop and become well-versed within the regulatory landscape.
- RAPS Regulatory Affairs Certification (RAC).
About Medtronic
Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.
