At Medtronic, you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. We believe in breaking down barriers to innovation in a more connected, compassionate world. Join us to lead with purpose and help drive positive change in the healthcare industry.
Job Overview
As a MDR Vigilance & Regulatory Affairs Specialist II, you will play a critical role in ensuring the safety, compliance, and effectiveness of Medtronic’s medical devices by supporting global regulatory affairs and vigilance activities. You will collaborate with cross-functional teams such as Design QA, R&D, Clinical Affairs, and Marketing to support product development and ensure compliance with Indian, US FDA, EU, and other applicable global regulations.
Key Responsibilities
Regulatory Affairs:
- Support global registration activities by preparing, reviewing, and filing premarket documents.
- Collaborate with business units and international regulatory teams to obtain marketing authorizations for assigned projects.
- Develop and execute regulatory strategies for new or modified products from concept through commercialization.
- Monitor and assess regulatory changes and provide insights on their impact.
- Communicate with regulatory agencies and maintain written communication with health authorities.
- Ensure compliance with product regulations for raw materials and prototypes.
- Participate in audits, inspections, and health agency evaluations.
Vigilance & Complaint Handling:
- Review, evaluate, and classify incoming product complaints related to the safety, quality, and effectiveness of medical devices.
- Determine reportability of complaints to government agencies, ensuring compliance with FDA and international reporting regulations.
- Write investigation summaries based on technical product analysis and work closely with internal teams such as Technical Services, Manufacturing, and R&D.
- Maintain records in a constant state of audit readiness, ensuring accuracy and timely reporting.
Required Knowledge and Experience
- Education: Bachelor’s degree in Medical, Mechanical, Electrical, Biomedical Engineering, Life Sciences, or related healthcare field.
- Experience: 4-7 years of regulatory and/or vigilance experience in the medical device or pharmaceutical industry.
- Skills:
- Strong understanding of Indian, US FDA, and EU regulations.
- Excellent written, organizational, and communication skills.
- Ability to multitask, work under pressure, and maintain attention to detail.
- Familiarity with computer applications such as Word, Excel, Access, PowerPoint, and database analysis.
Physical Job Requirements
This position may involve minimal travel and requires the ability to work under dynamic conditions.
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package, supporting employees at every stage of their career and life.
