Senior/Principal EU Regulatory Consultant

3 weeks ago

Bristol, United Kingdom NAMSA Full time

Senior/Principal EU Regulatory Consultant - Remote


NAMSA pioneered the industry and was the first independent company in the world to focus solely on Medical Device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider of laboratory, clinical and consulting services to the medical device sector. We provide support for clients during every step of the product development lifecycle and beyond.


We are seeking an experienced regulatory affairs professional with a deep understanding of the EU Medical Device Regulation (2017/745). You will be joining a dedicated team of subject matter experts (many of whom previously worked at notified bodies), where you can bring your own perspective and expertise, supporting manufacturers from around the globe to achieve CE marking.


Job Description:


· The main functions of the role are:

· Developing EU submission strategies for new devices

· Gap assessing MDD legacy device for actions to achieve MDR compliance

· Liaising with other experts (e.g. biological safety and medical writing) to ensure documentation meets MDR requirements

· Supporting MDR clients reviewing and drafting responses to notified body non-conformances

· Advising on strategies to leverage data from the ROW to support an MDR submission

· Supporting clients develop technical documentation for new and legacy devices

· Developing PMCF strategies to support ongoing safety and performance data

· Drafting specific annex II and III documentation for MDR compliance

· Providing medical device technical advice within your area of therapeutic expertise e.g. central circulatory system, orthopedics, neurology, electromedical, animal tissue, medicinal substance

· Proposing and implement systems to support internal improvement and NAMSA’s long-term growth.

· Offering opportunities to clients for expansion of services to be provided by NAMSA.

· Actively participate and lead meetings with prospective clients.

· Conducting training and/or seminars for clients on current and forthcoming regulatory topics

· Representing NAMSA as a speaker at national and international conferences and events, and where applicable national standards bodies.

· Develop positive relationships with clients, as well as with NAMSA colleagues.

· Ensure that deliverables are of high quality, given time and budget constraints.

· Functioning at a level that affords respect by internal NAMSA Associates/team members.


Requirements:

· Bachelor’s degree or equivalent experience in a related field, 7 years of relevant experience or Advanced Degree (Masters or PhD) with 5 years of experience.

· Extensive EU regulatory experience in the medical device industry is Required. Knowledge of other regional regulations are beneficial.

· Experience working as a notified body auditor or product expert is preferred.

· Strong written, verbal communication and interpersonal skills.

· Problem solving and/or troubleshooting experience.

· Project management experience.

· Fluency in English and local language, if different, required.

· Knowledge of and experience with Microsoft Office software.

  • · Ability to write and review complex document

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