Senior Compliance Specialist

Competetive

Malmesbury

Description

An experienced compliance professional is required to assist the Regulatory and Compliance Manager to meet Global Regulatory Affairs requirements affecting a range of products .

Market Overview

Home to our global Research, Design and Development centre and all of our Commercial functions, Dyson HQ is tucked away in countryside famous for the railway tunnels and bridges of Isambard Brunel, who revolutionised modern engineering. Our secluded location helps us to protect our ideas and stay independent-minded. Yet nearby are the fashionable cities of Bristol and Bath (where a young James Dyson invented cyclone technology).  In 2017, our HQ doubled its footprint with an ambitious new expansion. The building is the heartbeat of Dyson. Nearly 2,000 people, including James himself, spend their days strategizing, inventing technology and telling the Dyson story to the world.

Function Overview

For a Dyson engineer, breaking the rules is part of the job. It’s what makes Dyson machines different. But the next great Dyson idea can’t change the world from a lab. To ensure our machines can be sold, there are some rules we need to stick to. From reviewing initial concepts to testing final components in our accredited test laboratories, our Compliance and Approvals team is a critical voice during the design phase. By making sure Dyson machines are never kept off the shelf by global standards and legislation, they play vital role in supporting Dyson’s growth.

Accountabilities

  • Prepares Global RA strategies in association with Dyson affiliates.
  • Plans, prepares and co-ordinates the development of pre-market applications and related submissions to regulatory bodies, Notified Bodies and other regulatory agencies. 
  •  Provides guidance to cross functional product development teams regarding conformance with regulations, standards and guidance documents. Including data required to substantiate product claims and content of labelling, advertising and promotional materials. Interacts with regulatory authorities as required.
  • Develops international product registrations.
  • Provides guidance to product development teams regarding data and information required to prepare such registrations.
  • Develops regulatory labelling in accordance with specifications and approves proposed labelling, packaging, advertising and promotional materials after evaluating conformance to regulations and commitments made in clearance, approval or registration applications for the product.
  • Reviews and evaluates Global regulatory impact of proposed product changes in association with Dyson affiliates. Prepares submissions (or rational for justifying no submission) needed to approve such change.
  • Supports Global product removal and correction activities as required.
  • Performs directed activities and aids in preparation of documentation supporting product liability, legal actions and claims.
  • Interfaces with Dyson Technology Ltd and outside counsel as required.
  •  Participates in special assignments as required;
  • Provides guidance and support to other Regulatory staff and project team members.


Skills

Qualifications/Training

Essential:

A degree (or equivalent) in a scientific discipline.

Desirable: Regulatory Affairs Certified. (RAC). Knowledge of ISO requirements.


Experience Essential:

  • Regulated product design or development, diagnostic or related industry experience in regulatory affairs.
  • Knowledge and understanding of US, EU and Global regulations is essential.
  • Demonstrated success in preparing pre- marketing applications and CE mark technical file

Desirable:

  • Prior RA experience with regulated home/consumer or OTC products
  • Technical experience gained in an R&D laboratory setting.

Attributes/Characteristics

  • Ability to work independently and pro-actively.
  • Excellent analytical capability, written and verbal communication skills.
  • Independent problem-solving ability essential.
  • Ability to interface successfully with all levels of management, internal organization and external regulatory authorities.
  • Team player.
  • Strong interpersonal skills.
  • Ability to manage complexity.

Benefits Overview

Dyson monitors the market to ensure competitive salaries and pension contributions. Beyond that, you’ll also enjoy a profit-related bonus, generous leave and life insurance. But financial benefits are only the start of a Dyson career. Rapid professional growth, leadership development and new opportunities abound, driven by regular reviews and dynamic workshops. And with a vibrant culture, flexible working hours, the latest devices and a relaxed dress code reflecting our engineering spirit, it’s an exciting team environment geared to creativity, innovation and ambition.

Posted: 16-May-2018

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