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Senior Regulatory Affairs Specialist

Employer
NonStop Consulting
Location
Homeworking
Salary
Negotiable
Closing date
Feb 18, 2021

View more

Sector
Science, Chemistry, Analytical Chemistry
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional

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

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
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