Job Opening Biotechnology RA @ Novo Nordisk
Novo Nordisk Biotechnology RA Job Opening – Applications Invited
Novo Nordisk Biotechnology RA Job Opening – Applications Invited. MTech Biotechnology candidates are eligible to apply online for a RA Professional II – Medical Devices position that is available at Novo Nordisk, which is one of the world’s most successful pharmaceutical companies and with great growth potential.
Designation: RA Professional II – Medical Devices
Category: Regulatory
Location: Bangalore, Karnataka, IN
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 the device area as well as 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 also responsible for planning, coordination and executing the regulatory tasks as required for existing device products according to the Global Regulatory Device Strategy for the defined area of responsibility in collaboration with the manager as well as 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 present worldwide trends and also development within regulatory requirements for medical devices and also combination products.
7) Coaching and also training in regulatory requirements for medical devices and combination products.
Qualifications:
As a person, you are ambitious, proactive as well as capacity to interact with people at all levels in the organisation. You hold a Bio-Medical Engineer/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 relating to 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 also the effectiveness of medical electrical equipment).
- Experience in work with horizontal (e.g. system standards) along with vertical standards (more specific standards).
- Own development plan in cooperation with the line manager.
Get in touch with
For further information, please contact Shivalingappa at SVGK@novonordisk.com.
Deadline: 5-June-2020
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