Regulatory Affairs Professional require at Novo Nordisk | M.Pharm
Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : RA Professional II - Medical Devices
The Position :
As regulatory device professional your main function is to plan, prepare and submit high quality files to the authorities achieving fast approvals. Furthermore, to influence NNs position within device area and to communicate these within the organisation. The professional act as an ambassador for RA Durable Device & Needles outside the area, more specifically the regulatory device professional has the following responsibilities with specific focus on the device documentation
1) Prepare and responsible for planning, coordination and executing the regulatory tasks as required for existing device products in accordance with the Global Regulatory Device Strategy for the defined area of responsibility in collaboration with manager and colleagues.
2) Responsible for preparation and compilation of the individual sections of all files for the defined area of responsibility.
3) Facilitates approval of all files for the defined area of responsibility.
4) Responsible for the regulatory interaction concerning scientific issues with internal stakeholders, affiliates and health authorities for all files within the defined area of responsibility.
5) Responsible for updating or maintaining regulatory files within the defined area of responsibility, including evaluation of the regulatory implications of changes and necessary actions.
6) Follow-up on current world-wide trends and development within regulatory requirements for medical devices and combination products.
7) Coaching and training in regulatory requirements for medical devices and combination products.
• As a person you are ambitious, proactive and ability to interact with people at all levels in the organisation. You hold a Bio Medical Engineer/M.Pharm/M.Tech in Biotechnology.
• You are expected to have deep 3-9 years of In-depth knowledge on and experience within: Medical Device Directive 93/42/EEC
• FDA regulations regarding medical devices, e.g.:
- 21CFR part 807 (Establishment Registration)
- 21 CRF part 820 (Quality Systems Regulations)
• ISO standards, e.g. ISO13485, ISO14791, ISO 10993-series
• IEC 60601-1-series standards (safety and effectiveness of medical electrical equipment)
• Experience in work with horizontal (e.g. system standards) as well as vertical standards (more specific standards).
• Own development plan in cooperation with line manager
Qualification : M.Pharm/M.Tech in Biotechnology
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Medical Devices
End Date : 20th June, 2020
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