Regulatory Affairs Manager Bayer – in Delhi, Apply Now!
The Regulatory Affairs Manager – Medical Devices at Bayer India plays a crucial role in ensuring the compliance of radiology medical devices with Indian and South Asian regulatory standards. This position involves managing regulatory submissions, maintaining product documentation, and collaborating with internal teams to secure timely approvals. With expertise in India’s regulatory framework and strong communication skills, the ideal candidate will oversee regulatory processes, contribute to policy shaping, and ensure ongoing compliance with local regulations.
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
- Prepare the submission dossiers for India import license applications
- Provide regulatory responses to local health authorities
- Review device labelling materials for compliance as Regulatory Affairs
- Monitor and communicate new or updated regulations from India
- Support policy research and shaping activities
- Develop and maintain tracking of regulatory device activities
- Support various departments by providing regulatory information and advice
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
- Familiar with local regulations and regulatory assessment of design changes preferred for Regulatory Affairs
- Experience multitasking in a deadline controlled and highly regulated environment
- Detail oriented, well-organized, and motivated to work independently or in cross-functional teams
YOUR APPLICATION
Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation, etc. We are committed to treating all applicants fairly and avoiding discrimination.
Location: India : Delhi : New Delhi
Keywords: Manager Regulatory Affairs, Medical Dev, Bayer, India, Delhi, New Delhi
