Senior Regulatory Affairs Specialist, Pre-Market
As Senior Regulatory Affairs Specialist, you are part of the Regulatory Affairs department of our client. This department supports the International West region (Europe, MEA and Latin America), but has a strong focus on Europe due to the strict regulations in the EU. The (Senior) Regulatory Affairs Specialist works as a consultant and senior technical expert to the business unit for planning and execution of tactical and strategic regulatory programs, assessing regulatory risks, developing and implementing guidance programs in response to identified regulatory needs.
We offer you a position in which you manage submissions for new products and product changes as required to ensure timely approvals for market release and commencing clinical studies. You provide support for market-released products as necessary. This includes review of labeling, promotional material, product/manufacturing process changes. You monitor and report changes in the regulatory environment that impact our business and alert and advice management and implement practical guidance for the enterprise to minimize the regulatory risk. You provide input for regulatory strategies for new therapies and may be consulted by the business unit for regulatory issues. You prepare position papers on interpretation in order to get a harmonized approach within the region for the whole enterprise. You will also provide regulatory support to the business unit during inspections by European regulators and actively participate in CEN/CENELEC/IEC standardization activities as assigned product expert. Actively participates in the transposition of international standards into corporate or RA policies and procedures.
We are looking for candidates that have finished their Master preferably in the domain of Life Sciences. In addition to this degree you need to have 3-5 years of experience in Regulatory Affairs in Medical Device Industry. To be successful as a candidate in this position we are looking for people with experience in product development and clinical trials.
Our client offers you a professional, international, dynamic and high quality working environment, where personal development is stimulated and personal initiatives are encouraged. Your Development Plan will challenge you to further develop your personal skills and competencies, to build your career within our global organization
Yacht is a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on site and innovate together with our customers to find smart solutions. Being part of the world wide Randstad Group we have an extensive network of clients and professionals. Working as a high tech professional within Yacht means you will work on interesting and challenging long term projects for our clients in the Dutch “Brainport” Eindhoven region, mainly on projects at our clients’ Research & Development departments. Our Brainport region is considered to be the smartest region in the world! We cooperate with high tech companies that work on the cutting edge of technology. To give you an example of our portfolio: ASML, Philips Healthcare, Philips Lighting, Philips Research, TNO, FEI company, DAF, VDL ETG, Océ and many others.
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer +31 0655724609
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.