Senior Compliance Specialist
- 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.
A degree (or equivalent) in a scientific discipline.
Desirable: Regulatory Affairs Certified. (RAC). Knowledge of ISO requirements.
- 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
- Prior RA experience with regulated home/consumer or OTC products
- Technical experience gained in an R&D laboratory setting.
- 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.