Max. € 70,000
Quality & Safety
Detachering via YER
Over deze vacature
The Senior Regulatory Manager is part of the Regulatory Affairs Team of the Innovation Site Eindhoven (ISE). In this position, the Sr. Manager will responsible for leading High Profile Medical Device development projects for the Beauty business who is part of Personal Care. The Sr. Regulatory manager is a strategic partner for the business groups. The activities will focus on the hair removal devices called Lumea.
Start date = ASAP
Duration = at least 1 year, but realistically more project might be longer.
- Take “Regulatory Ownership” of the Medical Devices, being the primary point of contact for the development teams;
- Involved early in Advanced Development Projects and Value Proposition Creation;
- Involved in Clinical Claim Development;
- Create Assessments of Medical Device Classifications for applicable Markets globally;
- Create Regulatory Strategy Plan for new Lumea Hair Reduction device projects;
- Review Product Compliance Plans as created by Safety & Compliance Managers;
- Create Product Labelling Plan;
- Review Clinical Study Plan and Reports;
- Create Regulatory Medical Device Submission Packages for markets like EU, U.S., Brazil, China, ...
A high-tech company.
You will be employed by YER and seconded to our client. We offer:
- Good employee benefits (e.g. work-life balance, pension, lease car);
- Challenging assignments;
- Excellent guidance from your consultant and YER's back office;
- Development opportunities, including the YER Talent Development Programme with a personal coach;
- Intensive support for international candidates (including Dutch lessons, tax-return and accommodation assistance);
- Cooperative and results and relationship-driven;
- Friendly atmosphere and open culture;
- Community/network with other technology professionals from a variety of multinationals;
- Events and masterclasses with interesting speakers and attractive companies.
Senior Manager with strong commercial business sense, who has consumer safety and product compliance top of mind. Able to work in a high pressure, result driven, project environment. Strong communicator, collaborator, and team player. Excellent English language skills in writing and speech. Bachelor or university level of thinking.
Must have items
- 10-15 year experience in medical device regulations, in a commercial environment;
- Global medical device regulation knowledge for EU (MDD and EU-MDR), United States (FDA), Brazil (Anvisa);
- Proven successful track record in regulatory submissions for medical devices;
- Knowledge of Clinical Study setup, execution and reporting;
- Familiar with MDSAP and ISO 13485;
- Knowledgeable on Product Risk Assessment strategies;
- Strong Senior Personality being able to take position and guide a project team
Nice to have items
- Knowledge of different standards for household and medical devices (e.g. electrical standards);
- Knowledge on Software Development;
- Pharmaceutical background.