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Senior Regulatory Affairs Specialist

Employer
NonStop Consulting
Location
Homeworking
Salary
Negotiable
Start date
19 Jan 2021
Closing date
16 Feb 2021

View more

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

Job Details

My client is a Medical Device consultancy and Clinical Research Organisation that specialises in delivering compliance excellence for companies in the IVD, CDx and general medical device sectors.

They are currently looking for a Senior Regulatory Specialist to be an integral memeber of their team and play a significant pary in team projects in the development and delivery of global compliance solutions to client companies, ensuring that client objectives are met and exceeded at all times.

This will require the utilisation of a platinum standard approach to regulatory research, internal and external stakeholder satisfaction as well as an innate work ethic and attention to detail that is aligned with the company's core values.

Key Responsibilities:

  • Support the work of the company and project teams in the provision of specialised regulatory expertise to client companies, ensuring expectations and interests are met.
  • Contribute to the formulation and implementation of the short and medium-term Key Performance Indices/Indicators that allow for measurement of success.
  • Research and prepare elements of regulatory submission documents on behalf of client companies, including but not limited to clinical trial applications, study risk determination requests, IDE submissions, 510(k), PMA, CE technical files and design dossiers, PMDA briefing documents and submissions etc.
  • Assist wider team in understanding the regulatory requirements for an investigational device in the set-up, management & conduct of clinical investigations worldwide.
  • Prepare regulatory audit reports and gap analyses on behalf of client companies.
  • Manage and keep up to date information relating to regulatory requirements for CDx device studies and maintain the company's web-based clinical trial planning tool.
  • Work to manage and prioritise actions relevant to internal process development and client deliverables.
  • Contribute to the preparation of global clinical and regulatory guidance documents and white papers.
  • Design and deliver formal client presentations, including proposed solutions.

What you need:

  • Bachelor's Degree or above in a scientific or engineering subject
  • 3+ years General Medical Device/IVD industry experience in a product development or regulatory role

If you are interested then get in touch as soon as possible.

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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