IVD Regulatory Affairs Consultant

As a Regulatory Affairs Consultant at our company, you provide specialist consulting services directly to customers. This could involve supporting customers with FDA pre-submissions and 510(k) clearances , their transition from the IVDD to the IVDR gaining CE certification, approvals in other global markets for the first time, or preparing regulatory strategies.

As a consultant, no two days or customers are the same. You may be engaged to build a 510(k) submission or technical file reports to support CE certification, or similar global approvals. However, it could also include developing a regulatory strategy, product development planning, in-depth reviews of performance evaluation or risk management data, creating and reviewing quality management system policies and procedures, performing gap analyses, internal or supplier audits to support and improve customers quality systems or perhaps delivering customer training.

Our clients include the full spectrum from top 50 global IVD companies and pharma corporations with companion diagnostics to start-ups that we help to bring new innovations to global markets.

You will be part of a team. No one is an expert on everything, so we support each other to play to our strengths so that we provide the best service to customers. This position is a great opportunity to apply your expertise and continue to build your experience. We know how important it is for our customers that we maintain our experience to be state-of-the-art and we, therefore, hold monthly Qserve training days to ensure we provide consistent advice to customers as well as to continue to learn from each other.

• You have a technical or scientific degree (BSc, MSc, or Ph.D.) in (bio)chemistry, (medical) biology, biomedical technology, or similar.

• At least 7 years of working experience in the field of IVDs through positions in industry, or notified body, competent authority, or consultancy with one of the above.

• IVD experience with developing reagents, assays, near patient tests/point of care, self-tests/direct to consumer or working with software and/or the algorithms used to determine results; preferred.

• Knowledge of IVD regulations in the US and experience with pre-market submissions [pre-sub, PMA , 510(k), breakthrough, IDE]. Knowledge of IVD regulations in the EU, UK, Canada and/or Australia is considered an advantage but not essential.

• Familiar with medical device quality assurance but currently not looking for auditors or candidates limited to QMS only experience.

• Professional writing expertise particularly with technical documentation and regulatory documents.

• Pragmatic, enjoying a mix of activities in daily work.

• Communicative and service-oriented, supporting a wide variety of clients from small start-ups to large multinationals, able to adapt to different company cultures and situations and liaise directly with customers.

• Strong organizational skills, detail-oriented to deal with various projects at the same time.

• Fluent in English.

• Based in the United States