Beschreibung
Regulatory Affairs Manager (f/m/d)- medical device /RWD /IVD/Industry / GermanProject / 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:
This Regulatory Affairs function belongs to the Roche Core Lab Customer Segment. 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.
Perfect 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 have a focus on candidates with experience on software regulations.
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:
* 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;
- 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
* Global Regulatory Affairs Manager
- 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:
* Bachelor or Master Degree in Life Sciences
* At least 5 years of experience as a Regulatory Affairs Manager in IVD Instruments, electrical medical devices as a plus
* At least 5 years of experience with Development of IVD Devices, Hardware and Software of IVD Instruments as a plus
* Experience in industry
* Experience in supporting development projects
* Very good command of English is required
Nice to haves:
* German
* Experience in a regulated environment or experience in GxP
* Mechanical/Electrical Expertise
Reference No.: 920369SGR
Role: Regulatory Affairs Manager
Industry: Pharma
Location: Rotkreuz
Workload: 100%
Start: 01.07.2021
Duration: 12++
Deadline: 09.06.2021
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: .
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.