About Medtronic
Medtronic is dedicated to pushing the boundaries of technology, therapies, and services to improve patients’ lives. As a global leader in the healthcare industry, we strive to create meaningful innovations that address universal healthcare needs.
Position: Regulatory Affairs Specialist
Job Description
- 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 authorizations for assigned projects.
- Represent Regulatory Affairs as a team member of product development projects from Concept through Commercialization.
- Review pre-clinical and clinical protocols and associated reports for submissions.
- Develop Regulatory Strategies for new or modified products.
- Monitor changes in the regulatory environment and communicate relevant information.
- Interact with regulatory agencies and/or notified bodies on administrative matters.
- Document and maintain communication with health authorities.
- Prepare internal documents for device modifications.
- Participate in health agency inspections and audits.
- Author and/or review regulatory procedures and update as necessary.
- Review change control documents and assess regulatory impact.
- Ensure compliance with regulatory requirements for promotional material, advertising, and labeling.
Candidate Profile
- Bachelor’s degree in Medical, Mechanical, Electrical, Life Science, or related healthcare majors.
- 4-7 years of experience in regulatory affairs roles in the medical device and/or pharmaceutical industry.
- Good understanding of regulations and policies issued by India, US FDA, and EU.
- Excellent written, organizational, and communication skills.
- Strong attention to detail and ability to handle multiple tasks.
- Proficiency in English (reading, writing, speaking).
- Good learning attitude and self-motivated.
- Ability to establish credibility with all levels of the customer base.
Additional Information
- Experience: 1-7 years
- Qualification: Bachelor’s degree
- Location: Nanakramguda, Hyderabad
- Industry Type: Pharma/Healthcare/Clinical research
- Functional Area: Regulatory Affairs
- End Date: 25th May 2024