Regulatory Affairs Job at Medtronic
A unique opportunity has emerged for medical professionals to work as a Regulatory Affairs Specialist at Medtronic in Hyderabad. This Remote Regulatory Affairs Job offers a chance to contribute to innovative healthcare solutions while working in a flexible environment.
About Medtronic:
Medtronic is a global leader in healthcare technology, dedicated to alleviating pain, restoring health, and extending life. With a workforce of 95,000 employees across more than 150 countries, Medtronic prioritises patient care by developing innovative medical technologies that improve the lives of over 72 million patients each year. The organisation is committed to fostering a culture of purpose, growth, and impact.
Job Details:
- Job Title: Regulatory Affairs Specialist
- Location: Nanakramguda, Hyderabad, India
- Job Type: Full-time
- Job Requisition ID: R76878
- Work Arrangement: Remote with flexible work options
Job Description:
The Regulatory Affairs Specialist will be responsible for preparing, reviewing, and filing premarket documents for global registrations. Collaborating with various teams, the specialist will ensure compliance with regulatory requirements while supporting marketing authorizations for assigned projects. This role involves monitoring changes in the regulatory landscape and maintaining communication with health authorities.
Key Responsibilities:
- Prepare, review, file, and support premarket documents for global registrations for assigned projects.
- Collaborate with business unit and international regulatory affairs personnel to support marketing authorisations for assigned projects.
- Review pre-clinical and clinical protocols and associated reports for submissions.
- Develop regulatory strategies for new or modified products.
- Monitor and provide information on the impact of changes in the regulatory environment.
- Document and maintain communication with health authorities.
- Prepare internal documents for modifications to devices, when appropriate.
- Participate in health agency inspections and notified body audits as necessary.
Eligibility Criteria for the Remote Regulatory Affairs Job:
- Bachelor’s degree in medical, mechanical, electrical, life sciences, or other healthcare-related majors.
- 4-7 years of experience in a regulatory affairs role within the medical device or pharmaceutical industry.
- Good understanding of regulations and policies issued by India, the US FDA, and the EU.
- Excellent written, organisational, and communication skills.
- Strong attention to detail and ability to manage multiple tasks under pressure.
- Experience with project management and adherence to timelines.
Required Skills for the Remote Regulatory Affairs Job:
- US and global regulatory affairs knowledge and experience.
- Effective verbal and written communication skills.
- Strong interpersonal and negotiation skills.
- Proactive approach to developing regulatory knowledge.
- RAPS Regulatory Affairs Certification (RAC) is preferred.
This is an excellent opportunity for qualified candidates to join Medtronic as a Regulatory Affairs Specialist in Hyderabad. Those interested are encouraged to apply before the deadline to be part of a mission-driven organisation that is shaping the future of healthcare.
CLICK HERE TO APPLY NOW
