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Consultant QA/RA - Netherlands
Posted on : 24 May 2017
Consultant Regulatory Affairs
This is what you will be doing:
- As a Consultant QA/RA at our company you provide (depending on your background and experience) specialist consulting services, auditing and/or training in medical device regulations, quality assurance, regulatory compliance, clinical evaluation, and strategic support to medical device manufacturers. With the objective to obtain or maintain or expand market access for our customers to various markets (EU, USA, China) and based on predetermined and agreed deliverables.
As a consultant, you may build (technical) documentation and design dossiers in support of CE marking, 510(k), or similar approval processes.
- Your activities may include strategy planning, reviewing and/or developing technical files, clinical evaluations and quality management systems.
- You may conduct internal or supplier audits, deliver interim QA/RA management, or help improve our customers quality processes.
- You maintain, develop and share your expertise and knowledge on a specific expert area.
- On this specific expert area, you will be the point of contact for colleagues and customers.
- You will pro-actively follow the news and trends in the market to share in our Knowledge Center.
- In your expertise area you will be responsible for writing blogs, whitepapers, news items, presentations or similar to promote our knowledge base and the company brand.
And this is what you will bring:
- You have a technical or scientific degree (BSc, MSc or PhD) in physics, mechanical engineering, chemistry, (medical) biology, biomedical technology or similar.
- Minimal 3 to 5 years working experience in the field of medical devices through positions in industry, consultancy or regulatory agencies (Notified Bodies, FDA), in either manufacturing, R&D, quality or regulatory roles.
- Knowledge of Medical Device Regulations (CE, FDA, PAL, TGA, etc.) and/or quality assurance.
- Pragmatic, enjoying a mix of activities in technology, business processes, regulatory affairs, quality assurance or clinical affairs.
- Communicative and service oriented, supporting a wide variety of clients from small start-ups to large multi-nationals, able to adapt to different company cultures and situations.
- Strong organizational skills, detailed oriented to deal with various projects at the same time
- Fluent in English.
- Working permit and driver’s license for The Netherlands.