- 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 our Knowledge Center) (blogs, whitepapers, news items, presentations or similar to promote knowledge base and brand of the company).
- 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.
- Ability to work legally in the USA and driver’s license
Our company offers a generous compensation package, including:
- Competitive salary (based on experience)
- 401k plan and company match
- Health insurance and company assistance with premiums
- Vacation time