Join Our Team
Are you an experienced and passionate regulatory affairs professional in the area of medical devices and in vitro diagnostics? Do you want to be part of a global team and utilize your experience and knowledge to help ensure that good quality products reach those who need them without unnecessary delay?
Role: Senior Consultant
Team: Medical Device Division
Reporting to: Dr Tina Amini – Director, Medical Device division
In this exciting new role, you will be working closely with Dr Tina Amini, Director of the Division, to support the growth of our Medical Device Division.
As a Senior Consultant you will have the opportunity to provide strategic, regulatory, and technical support to medical device or in vitro diagnostic medical device manufacturers. Working together with our clients to define each project clearly and identify key milestones and project deliverables. Constantly working to find creative solutions, address changing expectations and resolve unexpected project concerns or time restraints. Ensuring a seamless high-quality service.
The work and client base are wide-ranging, allowing you to manage and contribute to a variety of complex projects working with clients ranging from large international companies to small local start-ups with the objective to obtain or maintain EU and/or US market access for the clients.
You will be pro-actively involved in identifying new opportunities, leveraging existing and new networks, assisting the director of medical device division and our business development colleagues to meet and maintain the objectives set out by the company.
The role also provides you with a great opportunity to develop professionally through attending conferences, professional association meetings, exhibitions whilst promoting our company expertise and thought leadership.
Key attributes of a successful Senior Consultant (Medical Device / In vitro Diagnostics)
- Excellent interpersonal, verbal, and written communication skills (in English)
- Thorough knowledge of the Medical Device and/or In vitro Diagnostic industry and proven networking abilities within the industry.
- Excellent problem-solving capability
- Ability to plan, coordinate and lead activities simultaneously on multiple projects with strong attention to detail
Experience and Qualifications
- Education to Bachelor’s/advanced degree level in a technical or scientific discipline; chemistry, biochemistry, biomechanical technology, or similar
- 7 to 10 years working experience in the field of medical devices through positions in industry, consultancy, or regulatory agencies (Notified Body, FDA)
- Knowledge of Medical Device and/or In vitro Diagnostic Medical Device Regulations (CE, FDA)
- Previous experience in leading the coordination and preparation of technical documentations to ensure alignment and compliance with regulatory requirements as well as with company policies
- Proven track-record of outstanding performance in interacting with customers and various internal organizations.
As well as being rewarded a competitive salary, we offer a flexible working culture, we truly believe in work/life balance and provide the flexibility to work from one of our offices* or from home depending on your needs and location. We continue to grow year on year whilst maintaining a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation with a local feel.
*(Current COVID guidelines are in place)
Application & Contact
If you are interested in learning more about this role, contact us at Recruitment@ndareg.com with the subject line: Senior Consultant - MDD attaching your CV and cover letter.
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