Regulatory Affairs Manager Job at Bayer – Apply Now!

Regulatory Affairs Manager Role – Medical Devices Job at Bayer India – Apply Now!

Bayer, a global leader in pharmaceuticals and medical devices, is hiring a Manager, Regulatory Affairs – Medical Devices in New Delhi, India. If you have 3-5 years of regulatory experience in the medical device or pharmaceutical industry, this is your opportunity to contribute to healthcare innovation with a company dedicated to “Health for All, Hunger for None.”

About Bayer

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ‘Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

REGULATORY AFFAIRS MANAGER ROLE DETAILS:

Job Title: Manager, Regulatory Affairs, Medical Dev

Location: New Delhi, India

Division: Pharmaceuticals

Job Req ID: 841709

REGULATORY AFFAIRS MANAGER ROLE 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 AS REGULATORY AFFAIRS MANAGER ROLE

• With the support from Global Device Regulatory Affairs teams, prepare the submission dossiers for India import license applications for Bayer Radiology medical devices.
• Provide regulatory responses to local health authorities as required in a timely, proactive, systematic, accurate manner, to ensure timely approval new licenses and proper maintenance for existing licenses.
• Provide device regulatory assessments (e.g. product development, life-cycle engineering changes, etc.) for India as per required timelines to theGlobal Regulatory Affairs teams.
• Review the device labelling materials to ensure the compliance to local labelling requirements.
• Monitor and communicate the new or updated regulations from India, as well as supporting the impact assessment and implementation strategy as needed; and ensure that the device regulatory requirements of India are kept up to date in database systems.
• Support the policy research and shaping activities as required for the India device business.
• Develop and maintain tracking of regulatory device activities, including submission prioritization, submission status tracking and submission dossiers archiving.
• Support Commercial, Supply Chain, Order to Cash, Legal, Quality and/or Services by providing requested information and advices from India regulatory standpoint.
• Work in close collaboration, ensuring alignment and effective communication with APAC Device Regulatory Head, India Commercial and Global Device Regulatory Affairs teams.

WHO YOU ARE FOR REGULATORY AFFAIRS MANAGER ROLE:

• PhD / Masters / Graduate in Engineering, Pharmaceutical, Chemistry or Biological Sciences.
• 3-5 years of proven India regulatory experience in pharmaceutical or medical device industry, including hands on India registration experience and direct working experience with CDSCO.
• Familiar with local regulations and regulatory assessment of design changes.
• Experience multitasking in a deadline controlled and highly regulated environment.
• Proven ability to communicate effectively in English both verbally and in writing.
• Skill and determination to reach successful outcomes in negotiations with both inside team clients and outside parties e.g., CDSCO.
• Detail oriented and well-organized.
• Motivated to work independently as well as with cross-functional teams.

APPLY ONLINE HERE

Keywords: Bayer, Regulatory Affairs, Medical Devices, India, Pharmaceutical, Chemistry, Biological Sciences, Regulatory Affairs Manager Role. 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 and Instagram.