Regulatory Affairs Specialist

Noord Brabant - Nederland - Life Sciences & Health Care - Medische apparatuur - Medisch - Professional Master

Do you want to set up the quality management system of a venture? Be involved and interaction notified bodies like FDA? Then Brunel has the right position for you!

Vragen? Neem contact op

Liza Hagen, Consultant

Solliciteer

Over deze functie

As regulatory affairs specialist you are responsible for: instruct, coach and facilitate project teams on the application of Regulatory Affairs. The application of legislation, standards and guidelines relevant for product development and manufacturing. To engage with Philips innovation services (PInS) sales as well as PInS customers related to the identification of relevant regulatory and compliance boundary conditions for the PInS assignment during the definition phase.

You will provide guidance and coaching to PInS development teams in order to work in line with applicable Quality Management Systems (QMS). This can be QMS of Royal Philips or PInS, or the QMS of the customers and identify risks of non-compliance in an early stage of the project and escalate these appropriately.

You will assist in establishing a structure and control measures for the project related documentation, the creation of relevant records and configuration management, (DHF, DMR, DHR and TPD). During a project you will assist the Project Leader in creating and maintaining the Product Risk Management and the Verification & Validation plans.

You are also responsible for creating, maintaining and reviewing (project and/or production) of Quality documentation, such as Quality & Regulatory documents, reports, procedures, work instructions, in line with the request of the customer and the applicable QMS.

You need to be able to give training's on Quality and Regulatory matters to PInS employees, Customers or relevant Suppliers on PInS projects.

You will participate in internal and external audits.

Over jou

- Master degree

- 4+ year work experience

- Knowledge of Medical Device regulatory requirements

- Experience with audits

- Experience with notified bodies like FDA / DEKRA

- Experience with setting up QMS

- You are also an inspiring and optimistic person who likes to work together with the team to get the job done

Wat wij bieden

As Regulatory affairs specialist at Brunel Engineering, you will be employed by Brunel. At Brunel Engineering your career is paramount. We offer you various training options to speed up your career. You will be guided within this process by a Brunel Consultant. You profit from a fixed monthly salary with bonus opportunity. In addition to good primary employment conditions, we also offer you excellent secondary employment conditions, including a favorable pension scheme and group discount on your health insurance policy and other individual insurance policies. Brunel also offers you fun extras in the cultural and sporting field. Because not everyone finds the same issues important, you also benefit from a flexible package of employment conditions, specifically geared to your situation. For example, you can decide for yourself whether you want to purchase extra days off. At Brunel you not only have the assurance of a contract, but also of a career.

Over ons

Philips Innovation Services creates the bridge from idea to market for each innovation journey. Making innovation work, is our drive as well as our deliverable. By bringing together all the required experience, expertise, methods and tools, we get things done. In a reliable, cost-effective way. On time. Driven by our deep technical creativity, we continue where others stop.

Samenvatting

  • Vacature nummer: PUB239020
  • Standplaats: Noord Brabant
  • Markt: Life Sciences & Health Care
  • Uren per week: 40
  • Branche: Medische apparatuur
  • Opleidingsniveau: Professional Master
  • Expertisegebied: Medisch
  • Sluitingsdatum: zaterdag 21 december 2019
Solliciteer

Vragen? Neem contact op

LH

Liza Hagen

Consultant Brunel Netherlands Eindhoven

+31 40 257 8205

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