Medtronic Hiring Regulatory Affairs Specialist
About Company:
At Medtronic, we push the limits of technology, therapies, and services to help alleviate pain, restore health, and extend life. We challenge ourselves to make tomorrow better than yesterday, making this an exciting and rewarding place to be.
Position Name:
Regulatory Affairs Specialist
Organization:
Medtronic
Location:
Nanakramguda, Hyderabad, India
Salary:
₹12.5 Lakhs to ₹20.1 Lakhs per year
Qualification:
B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Experience:
4 to 8 Years
Job Responsibilities:
- Prepare, review, file, and support premarket documents for global registrations.
- Collaborate with business unit and international regulatory affairs personnel for marketing authorizations.
- Represent Regulatory Affairs in product development projects from Concept through Commercialization.
- Review pre-clinical and clinical protocols for submission.
- Develop regulatory strategies for new or modified products.
- Monitor changes in the regulatory environment and provide relevant information.
- Communicate with regulatory agencies on administrative and routine matters.
- Maintain communication with health authorities.
- Prepare internal documents for device modifications.
- Participate in health agency inspections and notified body audits.
- Author and review regulatory procedures and update as necessary.
- Review change control documents and assess regulatory impact.
- Assist in maintaining regulatory files, records, and reporting systems.
- Review promotional material for regulatory compliance.
- Ensure compliance with regulations for MEIC-developed product materials and prototypes.
Minimum Qualifications:
- 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 or pharmaceutical industry.
- Understanding of regulations and policies issued by India, US FDA, and EU.
- Excellent written, organizational, and communication skills.
- Strong attention to detail and multitasking abilities.
- Proficiency in English (reading, writing, speaking).
- Good learning attitude.
Nice to Haves:
- Excellent communication and interpersonal skills.
- Self-motivated and positive.
- Ability to establish credibility with all customer levels.
A Day in the Life:
- Support Design and Development Control activities with regulatory requirements, direction, tactics, and strategies.
- Work collaboratively with all organizational departments to meet regulatory requirements.
