Medical Affairs Job at Medtronic
A unique opportunity has arisen for professionals seeking a Medical Affairs Job at Medtronic in Nanakramguda, Hyderabad, India. This position offers a flexible work arrangement and is ideal for candidates with a strong background in regulatory affairs within the medical device or pharmaceutical industry. Interested applicants are encouraged to apply soon, as this role promises to be impactful in the healthcare technology sector.
About Medtronic:
Medtronic is a global leader in healthcare technology, dedicated to alleviating pain, restoring health, and extending life. With approximately 95,000 employees operating in over 150 countries, Medtronic develops innovative medical technologies that improve the lives of more than 72 million patients each year. The organization is committed to putting patients first and shaping the future of healthcare, making it an excellent place for those pursuing a medical affairs job.
Job Details:
- Job Title: Regulatory Affairs Specialist
- Location: Nanakramguda, Hyderabad, India
- Job Requisition ID: R73651
- Time Type: Full time
- Posted On: Posted Yesterday
- Remote Type: Flexible Work Arrangement
Job Description:
The Regulatory Affairs Specialist will support Design and Development Control activities by ensuring compliance with regulatory requirements. This role involves collaboration with various organizational departments to achieve strategic goals. Key responsibilities include preparing and reviewing premarket documents for global registrations, collaborating with international regulatory personnel, and developing regulatory strategies for new or modified products.
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 authorizations for assigned projects.
- 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 their impacts.
- Document communication with health authorities.
- Prepare internal documents for modifications to devices.
- Participate in health agency inspections and audits as necessary.
Eligibility Criteria for this Medical Affairs Job:
- Bachelor’s degree in Medical, Life Science, or other healthcare-related majors.
- 4-7 years of experience in regulatory affairs 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 with a flexible, team-oriented attitude.
- Strong attention to detail and ability to manage multiple tasks under pressure.
- Proficient in English, including reading, writing, and speaking.
- Good learning attitude.
Required Skills for this Medical Affairs Job:
- Knowledge of US and global regulatory affairs.
- Experience working with cross-functional teams.
- Effective verbal and written communication skills.
- Problem-solving experience.
- Project management skills and adherence to timelines.
- Ability to work well under pressure in a dynamic environment.
- Highly organized and detail-oriented.
