Emergo is inviting applications from experienced, high caliber, European-based Medical Device specialists with the following attributes:
Education: Bachelor Degree required, preferably in area of life sciences, medical, or engineering
Experience: At least 5 years in a quality assurance or regulatory affairs role; previous consulting experience is an advantage.
Location: Although most positions will be home office based, candidates already based in the UK, Germany and/or northern Europe are preferred.
Successful candidates will demonstrate the qualifications and competency to support the following areas of medical device consulting in the role of:
Regulatory Affairs Consultant
Objective: To provide assistance to medical device manufacturing clients with developing regulatory strategies and obtaining premarket authorization for their products in key markets (primarily U.S., EU and Canada).
Range of Expected Activities:
- Research and advise on device classification and regulatory pathways and strategies.
- Prepare and submit regulatory premarket submissions (510(k), technical files, Canada MDLs); communicate specific requirements for effective submissions.
- Assist in addressing and responding to deficiencies of product submissions identified by regulatory bodies.
- Prepare meeting requests between clients and the FDA, and facilitate those meetings.
- Interact and negotiate directly with regulatory authorities and notified bodies on behalf of clients.
- Assist clients with other regulatory concerns, such as labeling, promotion, design change evaluation, etc.
- Author CERs to support CE marking.
- Review documentation and advise clients in developing more effective documentation, e.g., risk management, labeling, reports.
- Travel: 0% – 30%
In addition, all successful consultant candidates will possess the following qualities:
- Strong interpersonal skills and ability to work with all levels of a client’s organization.
- Effective technical writing skills.
- Ability to identify, understand and resolve issues.
- Professional, but friendly demeanor; diplomatic but assertive.
- Detail oriented
- Effectively manages one’s time to ensure that work is completed efficiently and within the budgeted time, and is capable of successfully working on multiple projects.
- Ability to understand the big picture and is business-focused.