Medtronic is one of the world’s largest medical technology companies, with a mission to alleviate pain, restore health, and extend life through innovative therapies. Known for its cutting-edge technologies, Medtronic is dedicated to addressing global healthcare challenges and improving patients’ lives. Join a team that thrives on innovation, passion, and collaboration. Together, we can push the boundaries of what technology and services can do to create a better tomorrow.
Job Responsibilities
As a Regulatory Affairs Specialist at Medtronic, you will play a critical role in ensuring the compliance of Medtronic’s products with local and international regulatory standards. Your main responsibilities include:
- Document Coordination and Preparation: Prepare regulatory submissions and renewal documents for product approvals and label variations.
- Regulatory Compliance: Ensure that products, processes, and practices meet all regulatory requirements for medical device registration, importation, and clinical trials.
- Labeling and Manufacturing Guidance: Recommend necessary changes for labeling, clinical protocols, manufacturing, and marketing to ensure regulatory compliance.
- Interaction with Regulatory Agencies: Engage directly with regulatory agencies, such as CDSCO, FDA, and CE, ensuring adherence to the latest guidelines and procedures.
- Tracking and Control Systems: Monitor and improve regulatory tracking systems to ensure timely approvals.
- Clinical Trials and Approvals: Develop strategies to accelerate approval processes for clinical trial applications and other regulatory activities.
Qualification Requirements
To be eligible for this role, candidates must meet the following qualifications:
- Educational Qualifications: A B.Pharm or M.Pharm degree or a Bachelor’s or Master’s Degree in Biomedical Engineering or Science with formal training in Regulatory Affairs.
- Experience: At least 3-6 years of experience in the pharmaceutical, medical device, or life sciences industries, with 2-3 years of experience specifically in regulatory affairs for medical devices.
- Regulatory Knowledge: In-depth understanding of regulatory requirements in India, including medical device registration, importation, and clinical trials. Familiarity with CDSCO, FDA, CE, and other regulatory standards is crucial.
Skills Required
Successful candidates will exhibit the following skills:
- Strong Communication Skills: Excellent verbal and written communication in English is essential for interacting with colleagues, management, and external regulatory authorities.
- Interpersonal Abilities: Ability to build strong relationships with regulatory agencies and other stakeholders.
- Self-Motivated: A positive, “can-do” attitude with the ability to work independently or as part of a team.
- Customer Focus: Strong focus on understanding and meeting the needs of customers, both internal and external.
- Technical Knowledge: Familiarity with Quality Systems, Design Control, and regulatory aspects related to product design, manufacturing, and release.
How to Apply
Interested candidates who meet the required qualifications can apply for the Regulatory Affairs Specialist position at Medtronic through the company’s careers portal. The position is located in Gurgaon, and the application deadline is 30th January 2025.
To apply, follow these steps:
- Visit the Medtronic careers page.
- Search for the Regulatory Affairs Specialist role in Gurgaon.
- Submit your updated resume along with a cover letter that highlights your relevant experience and skills.
- Complete any additional required forms and submit your application.
