Medtronic has opened a Regulatory Affairs Specialist position in Nanakramguda, Hyderabad, offering an opportunity for experienced professionals to work on regulatory submissions, product registrations, compliance assessments, and international regulatory requirements.
The role is suited to candidates with 4–7 years of Regulatory Affairs experience in the medical device and/or pharmaceutical industry and knowledge of regulatory requirements across India, the US FDA, and the European Union. The position is full-time with a flexible work arrangement.
Job Highlights
| Details | Information |
|---|---|
| Company | Medtronic |
| Position | Regulatory Affairs Specialist |
| Location | Nanakramguda, Hyderabad, India |
| Job Type | Full Time |
| Work Arrangement | Flexible Work Arrangement |
| Experience | 4–7 Years |
| Industry | Medical Devices / Pharmaceutical |
| Requisition ID | R73651 |
Roles and Responsibilities
The selected candidate will support regulatory activities throughout product development and registration processes. Key responsibilities include:
- Prepare, review, file, and support premarket documentation for global product registrations.
- Collaborate with business units and international Regulatory Affairs teams to support marketing authorizations.
- Review pre-clinical and clinical protocols and related reports for regulatory submissions.
- Develop regulatory strategies for new or modified products.
- Monitor regulatory changes and assess their potential impact on products and business activities.
- Maintain communication and documentation involving health authorities.
- Prepare regulatory documents for product and device modifications.
- Compile documentation required for submissions, license renewals, and annual registrations.
- Participate in health agency inspections and notified body audits when required.
- Author and review regulatory procedures and update them when necessary.
- Review change-control documentation and determine regulatory impact through formal assessments.
- Support the maintenance of regulatory files, records, and reporting systems.
- Review promotional materials, advertising, and labeling for regulatory compliance.
- Support compliance activities related to clearance and approval of product raw materials and prototypes.
Required Qualifications
Candidates should meet the following requirements:
- Bachelor’s degree in Medical, Mechanical, Electrical, Life Sciences, or another healthcare-related discipline.
- 4–7 years of Regulatory Affairs experience in the medical device and/or pharmaceutical industry.
- Understanding of regulations and policies issued by India, US FDA, and EU authorities.
- Ability to interpret international regulatory requirements.
- Strong written, verbal, organizational, and communication skills.
- Strong attention to detail with the ability to manage multiple tasks.
- Good planning skills and the ability to work under pressure.
- Strong English reading, writing, and speaking skills.
- Positive learning attitude.
- Ability to work effectively in a flexible, team-oriented environment.
Preferred Skills
Medtronic also values candidates who have:
- Knowledge and experience in US and global Regulatory Affairs.
- Experience working with cross-functional teams.
- Strong problem-solving abilities.
- Project management experience and the ability to meet timelines.
- Excellent organization and attention to detail.
- Ability to perform effectively in a dynamic work environment.
Salary and Benefits
Medtronic states that it offers a competitive salary and flexible benefits package, with compensation and benefits designed to support employees throughout different career and life stages. The position is also eligible for the Medtronic Incentive Plan (MIP), a short-term incentive program.
The exact salary for requisition R73651 is not disclosed in the supplied vacancy details. For the JobPosting schema, an indicative market-aligned range of ₹8–12 lakh per annum is used rather than presenting it as an officially confirmed Medtronic salary.