Senior Specialist/Asst Manager RA (IC Role)
- Delhi
- Permanent
- Full-time
- Develop timelines, coordinate receipt of technical information from global RA and independently execute new product
- Review technical documents before submission to external party and/or Health authority to ensure the documents
- Monitor and update registration activities and/or status to all relevant stakeholders on a regular basis. Ensure the
- Demonstrate strong understanding of MDR 2017 and associated regulations (LMR, DPCO, Drugs and Magic remedies
- Timely assessment of incoming changes to global and keep business aligned on impact, if any.
- Oversee India supplementary labeling compliance along-with QA.
- Take lead in project planning, budget review and support in managing RAQA KPI metrics.
- Lead cross-functional discussions with Supply chain planning and L&D operations team to maintain uninterrupted
- Mentoring new team member/associates and lending support in acquiring know-how required to work under minimal
- Provide timely intel to reporting manager in sending out key communication, internal document modification to ensure
- Monitor changing/new requirements and prepare policies, guidelines, training for employee, to ensure awareness and
- Provide support to Institution business team on tender related requests.
- The ideal candidate would have a diploma/degree in a scientific discipline such as Biology, Microbiology, Pharmacy,
- Minimum 5 years of experience in Medical devices regulatory affairs and 7-8 years of working experience in a Medical
- Good working knowledge of MS-EXCEL and PowerPoint will be preferred.
- Team player having an analytical and problem-solving mindset.
- Highly motivated, willing to learn and having an open mindset.
- Must be approachable and have a positive mindset
- Flexible and adaptable to changing environment and needs
- Must be a patient listener, and have a rational mindset towards solving problems.
- Demonstrate strong integrity in dealing with different external stakeholders