Life Sciences Regulatory Affairs Job at Medtronic – Apply Online Now
Regulatory Affairs Specialist
Locations: Nanakramguda, Hyderabad, India
Time Type: Full time
Posted On: Posted Yesterday
Job Requisition ID: 240007V8
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Careers that Change Lives
Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing, and Operations. Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met. Responsible for supporting the needs of the MEIC with regulatory support for research and development activities and ensuring Indian and other applicable regulations and policies are met.
A Day in the Life
Supporting Design and Development Control activities with regulatory requirements, direction, tactics, and strategies and working in a team environment with all organizational departments.
Job 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 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 to be used in submissions for assigned projects.
- Develop Regulatory Strategies for new or modified products for assigned projects.
- Monitor and provide information pertaining to the impact of changes in the regulatory environment.
- Communicate with regulatory agencies and/or notified bodies on administrative and routine matters.
- Document, consolidate, and maintain oral and written communication with health authorities.
- Prepare internal documents for modifications to devices, when appropriate.
- Participate in health agency inspections & notified body audits as necessary.
- Author and/or review regulatory procedures and update as necessary.
- Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.
- Assist in the development/maintenance of regulatory files, records, and reporting systems for systematic retrieval of information.
- Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.
- Ensure compliance with regulations specific to clearance and approvals of MEIC-developed product’s raw material and/or prototype.
Minimum Qualifications
- Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare-related majors
- 4-7 years of experience in RA roles in the medical device and/or pharmaceutical industry
- Good understanding of regulations and policies issued by India, US FDA, and EU, and ability to interpret international regulatory requirements.
- Excellent written, organizational, and communication skills, and a flexible and team-oriented attitude.
- Strong attention to detail and ability to handle multiple tasks, good at planning, and can work under pressure.
- Proficient in English, including reading, writing, and speaking.
- Good learning attitude
Nice to Haves
- Excellent communication and interpersonal skills
- Self-motivated and positive
- Ability to quickly establish credibility with all levels of the customer base
Keywords: Regulatory Affairs Specialist, Medtronic, Nanakramguda, Hyderabad, India, Full-time, Job Posting. Life Sciences Regulatory Affairs Job at Medtronic – Apply Online Now. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
