Novo Nordisk RA Professional Vacancy – Pharma Jobs
Novo Nordisk Pharma Job – Pharma Apply Online. Postgraduate and undergraduate pharma candidates apply. candidates are eligible to apply online for an RA Professional II – Medical Devices post. RA Professional II – Medical Devices job opening at Novo Nordisk. Check out all the details on the same below:
Job Title: RA Professional II – Medical Devices
As a person, you are ambitious, proactive and ability to interact with people at all levels in the organisation. You hold an M.Pharm
- 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
About the department:
Global Regulatory Affairs (GRA) in Bangalore consists of eight departments that work across our global processes and support both colleagues in Head Quarter Denmark (DK) as well as colleagues in our affiliates all over the world. As the area is growing, the total area will by midyear 2019 consist of approximately 120 dedicated employees. Regulatory Operations, Global Service Centre (GSC) is an integral part of Regulatory Operations DK. The objective of this team is to ensure efficient and competitive Regulatory Operations to support Regulatory Affairs HQ and RA Affiliates. The team provides the services in Submission Management, Regulatory Information Management and Operational Graphic Design.
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 the 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 a 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.
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