Bayer Hiring: Regulatory Affairs Manager Medical Devices- Chemistry Graduates Can Apply
Bayer, a global leader in healthcare and innovation, is hiring a Regulatory Affairs Manager – Medical Devices in India. This role involves overseeing regulatory strategy and compliance for radiology medical devices, ensuring timely approvals and marketability across South Asia. If you have expertise in medical device regulations, compliance, and policy research, this is your chance to be part of a visionary company shaping the future of healthcare. Apply now!
Manager Regulatory Affairs, Medical Dev
Position Purpose:
The Regulatory Affairs Manager – Medical Devices will be responsible for managing the regulatory strategy and ensuring the compliance of radiology medical devices with applicable regulations. This role involves working closely with internal teams, including global regulatory affairs, commercial, supply chain, quality assurance, legal, etc. to navigate the regulatory approval process for medical devices. The manager will monitor regulatory changes, support product submissions, and ensure timely approvals to maintain product marketability in India and some other South Asia markets. Additionally, the role will involve managing interactions with regulatory agencies, maintaining product documentation, and ensuring ongoing compliance with relevant standards and guidelines.
Your Tasks and Responsibilities for Bayer Regulatory Affairs Manager
- Prepare the submission dossiers for India import license applications for Bayer Radiology medical devices.
- Provide regulatory responses to local health authorities in a timely and accurate manner.
- Review device labeling materials to ensure compliance with local requirements.
- Monitor and communicate new or updated regulations from India.
- Support policy research and shaping activities for the India device business.
- Develop and maintain tracking of regulatory device activities.
Who You Are:
- PhD / Masters / Graduate in Engineering, Pharmaceutical, Chemistry, or Biological Sciences.
- 3-5 years of proven India regulatory experience in pharmaceutical or medical device industry.
- Experience multitasking in a deadline-controlled and highly regulated environment.
- Detail-oriented and well-organized.
Keywords: Manager Regulatory Affairs, Medical Devices, India, Regulatory Strategy, Compliance, Medical Device Industry, Job
