Regulatory Affairs Manager

Regulatory Affairs Manager (f/m/d) – IVD / Software / Medical Devices / Risk Manager / English

Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Regulatory Affairs Manager.

Background:
This Regulatory Affairs function belongs to the Roche Core Lab Customer Segment Automation. 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.

This position will be focused on project support for instruments so regulatory expertise in the field of regulated instruments and SW is a must. We are looking for candidates with good knowledge of the EU (IVDR) and some insights into international registration. Experience in assuming a regulatory role within a development project is needed.

Ideal Candidate:

Due to a high and unexpected workload, the team is looking for an additional team member. This person should have minimum 4 years of experience in regulatory affairs, working on development projects for medical devices (preferably IVD, MD also possible). This experience should be from the industry (no academics). We need someone with experience with software regulations. Please note on this opening, we are not necessary looking for a specific background (chemist, doctors etc). The focus really is on a strong regulatory experience within IVD instruments. IVD products are Class A products.

On a soft skill note, we need someone with excellent communications skills able to simplify complex subjects, someone with very good negotiation skills and proactive.

Tasks & Responsibilities:
– 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;
– Escalates project related regulatory issues;
– Review of labelling
– Assemble the documents and the project deliverable (or coordinate the activities) for the preparation of world-wide registration and resolution of possible conflicts.
– Administration of Product declarations, Certificates and other, similar documents
– Interaction with other regulatory functions: Define and implement necessary processes, strategies and SOPs to manage the interfaces within the assigned area; ensure the interface function between employer and Regulatory Affairs teams for the product approval/clearance in the country of interest.
– 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); provide support for specific topic/questions

Must Haves:
– At least 5 years of experience as a Regulatory Affairs Manager in IVD Instruments
– At least 5 years of experience with Development of IVD Devices
– Regulatory Affairs experience with software development
– Experience with risk management
– Very good command of English is required
– Bachelor or Master Degree in Life Sciences or Engineering

Nice to have:
– German
– Experience with electrical medical devices
– Hardware and Software of IVD Instruments as a plus

Reference Nr.: 921853
Role: Regulatory Affairs Manager
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 100%
Start: asap
Duration: 1 year with extension possible
Deadline: 24.08.2022