Medtronic Hiring Regulatory Affairs Specialist Opportunity For Life Sciences – Apply Now!
Regulatory Affairs Specialist
Nanakramguda, Hyderabad, India
ID: 240005EB
Job Description
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.
Must Have
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 preclinical 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 and 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 the clearance and approvals of MEIC-developed products’ raw material and/or prototypes.
Minimum Qualifications
- Bachelor’s degree in medical, mechanical, electric life science, or other healthcare-related majors.
- 4-7 years of experience in an RA role in the medical device and/or pharmaceutical industry.
- Good understanding of regulations and policies issued by India, US FDA, and EU, and the ability to interpret international regulatory requirements.
- Excellent written, organizational, and communication skills, and a flexible and team-oriented attitude.
- Strong attention to detail and the ability to handle multiple tasks, with good planning skills and the ability to work under pressure.
- Proficiency in English, including reading, writing, and speaking.
- Good learning attitude.
Nice to Have
- Excellent communication and interpersonal skills.
- Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.
- Self-motivated and positive.
- Ability to quickly establish credibility with all levels of the customer base.
Interested candidates can apply here.
Keywords: Regulatory Affairs Specialist, Medtronic, Job Posting, Regulatory Affairs, Medical Technology, Healthcare, Nanakramguda, Hyderabad. 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
