Specialist- Commercial Regulatory Affairs
Danaher
Beckman Coulter Life Sciences seeks a Commercial Regulatory Affairs Specialist to manage import licenses, renewals, and post-approval applications for medical devices and IVDs across India, Sri Lanka, and South Asia. The role involves regulatory submissions, authority correspondence, cross-functional collaboration, and guidance on labeling and manufacturing changes.
Responsibilities
- Prepare and submit import license applications, renewals, and post-approval change filings
- Coordinate with Business Unit Regulatory Affairs teams to gather required documentation
- Respond timely to regulatory authority queries and manage project timelines
- Collaborate with cross-functional teams on in-country testing and product registration needs
- Provide regulatory guidance on labeling, promotional materials, and manufacturing or packaging changes
Requirements
- Bachelor's degree in Science, Pharmacy, or related field
- 7–8 years of experience in medical device or IVD registration processes
- Deep knowledge of India Medical Device Regulations 2017 and amendments
- Demonstrated analytical, problem-solving, and negotiation skills
- Experience in matrix organizations and international regulatory environments
- Proficiency in MS Office and IT systems; self-directed project management
Rs 2.1 - 2.9 lakhs p.a.
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