Beschreibung
Regulatory Affairs Manager (f/m/d)- medical device /RWD /Software/Industry / RWDProject / Role:
For our client Roche Diagnostics International AG in Rotkreuz we are looking for a highly motivated and qualified Regulatory Affairs Manager (f/m/d)
Background:
Who We Are
Roche Diagnostics International Ltd in Rotkreuz 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 Roche Diagnostics main sites.
The Position
This Regulatory Affairs function belongs to the Roche 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:
should have minimum 3/4 years of experience in regulatory affairs: Medical Devices experience. 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-on global regulatory affairs
* Experience in global regulatory affairs working on development projects in medical devices (MD or IVD)
* Experience in industry
* Experience with software (working with instruments)
* Master degree (microbiology or chemistry) or an engineering degree
* RWD knowledge / understanding
* Excellent communications and negotiations skills
Reference No.: 920152SGR
Role: Regulatory Affairs Manager
Industry: Pharma
Location: Rotkreuz
Workload: 100%
Start: 16.04.2021
Duration: 12++
Deadline: 17.03.2021