Regulatory Affairs Manager

Regulatory Affairs Manager – IVD / Hardware /Software/Microbiology / RWD

Project / Role:
For our client based in Rotkreuz we are looking for a highly motivated and qualified Regulatory Affairs Manager.

Background:
Client is one of the world’s leading providers of diagnostic system solutions for clinics, laboratories and doctors’ offices. The company employs over 2200 people in Rotkreuz and is one of the client’s main sites.

The Position This Regulatory Affairs function belongs to the clients Centralized and Point of Care Solutions (CPS) business area and supports in addition DIA Solution Integration and Services. As Regulatory Affairs we support instrument and systems projects and the related product portfolio. This role is responsible for activities associated with regulatory approval of in vitro diagnostic medical devices including the overall development, implementation and coordination of regulatory strategies and activities with a focus on hardware and software products and projects. Responsible for assessment of device changes for regulatory implications.

Perfect Candidate:
Due to a high workload, the team is looking for an additional team member. This person should have minimum 3/4 years of experience in regulatory affairs: in in vitro diagnosis devices. This experience should be from the industry (no academics). We need someone with experience with hard and software regulations as well (experience with instruments rather than liquids or active substance). New regulations were implemented and will be coming in full effect by next year (IVDD vs IVDR to be implemented). The team is looking for support on this specific task, which will include a lot of documentations and updates.
On a soft skill note, we need someone with excellent communications skills able to simplify complex subjects and someone with very good negotiation skills.

Tasks & Responsibilities:
1) Project Lead Regulatory, within the scope of a project for new products or during the product lifecycle:
* Provides regulatory support to the R&D Project teams with the applicable Design Control processes
* Provides team members ad hoc specific education;
* Provides qualification and classification of the development object and related submission strategy;
* Interfaces with the correspondent RA-FL for submission strategies, planning and support; * Escalates project related regulatory issues;
* Review of labelling
* Assemble the documents and the project deliverable (or coordinate the activities) for the preparation of worldwide registration and resolution of possible conflicts.
* Administration of Product declarations, Certificates and other, similar documents

2) Global Regulatory Affairs Manager – interaction with other regulatory functions:
* Ensure the interface function between employer and Regulatory Affairs teams for the product
approval/clearance in the country of interest.
* Inform Global Regulatory Affairs Business areas about changes
* Inform Global Regulatory Affairs Business areas about relevant issues during product development and life cycle management

3) Global Regulatory Affairs Manager – interaction with functions other than regulatory functions:
* Education of staff members of R&D and Portfolio Management on regulatory related topics (e.g. Regulations or changes in the regulations).
* Accomplish of conformity evaluation including compilation of the conformity declaration for new and existing products. * Provide support for specific topic/questions 4) Global Regulatory Affairs Manager-General Task
* Define and provide Training on Regulatory submission topics
* Monitor regulatory requirements, including communication and distribution in a level appropriate manner
* Implementation of divisional and local-strategies

Must haves:
* Minimum 3/4 years in hands regulatory affairs in in vitro diagnostic medical devices
* Experience in industry
* Experience with hard and soft wares (working with instruments)
* Scientific degree (microbiology or chemistry) or an engineering degree
* RWD knowledge / understanding
* Excellent communications and negotiations skills

Reference No.: 920055 AD
Role: Regulatory Affairs Manager
Industry: Pharma
Location: Rotkreuz
Workload: 100%
Start: 16.03.2021
Duration: 12 month

Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com. Contact us for further information regarding our company, our positions or our attractive payroll-only-program: +41 41 760 77 01.

About us: ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.