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Senior Regulatory Affairs Specialist

Employer
NonStop Consulting
Location
England
Salary
Negotiable
Start date
16 Jun 2021
Closing date
21 Jun 2021

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Senior Regulatory Affairs Specialist - Enjoy UK's beautiful South-West!

My client is an innovative Medical Device company located in the beautiful area of the South-West UK and is looking for a Regulatory Affairs Specialist. By living and working in an environment that is well known for its green landscapes and beautiful coastlines you will be able to enjoy quiet weekends in nature with friends and/or family.

One of your key roles will be in assisting with multiple overseas product registration activities to over 70 countries so you will develop and share your knowledge and become a point of reference within and outside the company and as a result you'll be expanding your network.

Benefits:

  • Great opportunities to go for small trips to the coast to blow of some steam
  • The area offers low cost of living
  • Enjoy the open company culture and be able to share your opinion and communicate close with the director

Responsibilities:

  • Assist with the management and completion of New Product introduction, Change notes and update databases, as required.
  • Assist and communicate with International Regulatory Competent authorities such as MHRA (UK), FDA (USA), Health Canada and other overseas authorities, as required.
  • Regulatory assistance and support to PS Manufacturing, Sales and Customer services teams, as required.

Requirements:

  • Ability to assist and communicate with Regulatory Notified Body auditors, Customer auditors during Surveillance audits, Product Technical File audits, as required
  • Have a good understanding of European Medical Device Regulations, namely, MDD, MDSAP and forthcoming MDR requirements
  • You will have a clear understanding of various Key Regulatory and Technical CE documentation requirements to ensure continuing conformity to latest standards and regulations.
  • Fluent in English

If this job appeals to you please apply here or on the NonStop Consulting website or send it to me, Gilson Heitinga, on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.

Company

NonStop Consulting is an international recruitment consultancy renowned for a high level of service, professionalism, unrivalled industry knowledge and extensive industry networks.

With over 100 multilingual recruiters covering the life sciences industry across Europe, we take the time to get to know you – your wants, needs and aspirations. We then work tirelessly to match you with an employer that both matches your requirements and is the right cultural fit for you.

Underpinned by our in-house Quality Assurance team, our relationship with job seekers is fully transparent and truly consultative. Our recruitment consultants pay attention to every detail and pride themselves on being open and honest, ensuring the right opportunities for you as well as valuable feedback.

We are active members of APSCo, the Association of Professional Staffing Companies – a recognised badge of quality with the recruitment industry.

If you want to find out more about how we can help you, get in touch!

Company info
Website
Telephone
+41 (0) 435 080 817
Location
24 Poststrasse
Zug
6300
United Kingdom

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