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Regulatory Affairs Specialist

2 months ago

Bedford, Bedford, United Kingdom SPD Development Company Limited Full time
Job Description

Company Overview

SPD Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design, and marketing of advanced consumer diagnostic products.

We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products.

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist - Innovation to join our Regulatory Affairs team on a Full-Time, Permanent Contract.

The successful candidate will support our product portfolio transition from IVDD to IVDR, and also the regulatory strategy and implementation for assigned new product development projects as directed by the Regulatory Affairs Manager - Innovation and the Regulatory Director.

Key Responsibilities

  • Provide technical regulatory knowledge and guidance on global regulations, specific to In Vitro Diagnostic Medical Devices (IVD) and Medical Devices (MD).
  • Examine new legislation and implement into processes if required, with initial focus on requirements as part of the IVDD to IVDR transition.
  • Support new product concept work and business development (third party sourcing) projects.
  • Advise teams on the regulatory environment and requirements associated with the products being investigated.
  • Identify compliant solutions to regulatory problems that represent the least burdensome route.

Requirements

  • Minimum of BSc degree or equivalent experience in life sciences (e.g. biological sciences, biochemistry, pharmacology etc.).
  • Extensive hands-on experience in IVD or Medical Device Industry.
  • Comprehensive knowledge of ISO 13485, European regulations for medical devices, FDA regulations for medical devices, Canadian Medical Device Regulations and other international standards and regulations for IVD and medical device products.
  • Experience of working with Notified Bodies and regulatory agencies.
  • Prior experience of working with or within start-up companies is desirable.

What We Offer

  • Hybrid working.
  • Annual discretionary bonus.
  • 25 days paid annual leave plus bank holidays.
  • Company pension scheme including competitive employer's contribution.
  • Private Medical Insurance package with additional medical cash plan scheme.
  • Enhanced maternity and paternity pay.
  • Company supported employee Health & Wellbeing programme.
  • Life assurance.
  • Free electrical car charging points.
  • Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road & rail).