Head of Registration

Location Worthing
Discipline: Regulatory Affairs
Job type: Permanent Full Time
Job ref: 002425
Published: about 1 year ago

We are looking for an established Regulatory Affairs professional with management experience to oversee our global programme of medical device registration activities for our ophthalmic product range, which includes intraocular lens (IOL) implants, IOL delivery devices, ophthalmic viscosurgical devices (OVDs), and eye drops.


The Head of Registration will be leading the registration team within the RA department and supporting the Director of Regulatory Affairs in the daily oversight of quality system activities (assessment of changes for regulatory impact, review and creation of procedures, etc.)


Ambition: We play to win.

Focus: We put patients first. 

Integrity: We keep our promises.

Openness: We are passionate about new ideas.

Respect: We support each other.

Your key responsibilities will be:

  • Participate as a member of new product development teams;
  • Co-ordinate submission team meetings to prepare and submit regulatory dossiers and other related submission documentation
  • Be responsible for managing the development of regulatory strategies and authoring of registration documentation necessary to obtain market approvals for Rayner medical devices worldwide
  • Deputise for the RA Director as required
  • Co-ordinate internal resources to ensure submission timelines are met and provide regular updates to senior management on progress and alerts before any deadlines are due
  • Develop and follow internal SOPs and maintain systematic records and comprehensive documentation of submission activities and correspondence
  • Manage follow up-communications to regulatory authorities, to ensure that all responses to questions are responded to in the required timelines.
  • Ensure that new product submissions meet the minimum regulatory thresholds to avoid deficiency letters and “refusal to file” letters from regulatory authorities
  • Maintain regulatory submissions calendar and database of specific product listings, registrations and approvals worldwide
  • Participate as a regulatory representative in the Change Control Board, CAPA, complaints meetings etc and ensure that all regulatory documentation/technical documents are updated on approval of any related product/process changes
  • Keep abreast of regulatory requirements. Make Rayner top management aware of international developments for Medical Device registration requirements. Provide updates and reports as required.
  • Be an ambassador for regulatory affairs internally and externally, providing guidance and training to support submission activities
  • Be an inspirational leader and mentor to the registration team; generate and track KPIs to help drive high performance in the Registration team.
  • Other tasks reasonably required to support the activities of the regulatory affairs department and company of Rayner Intraocular Lenses

Qualifications & Experience:


  • Experience of international regulatory requirements for Medical Devices within developed and emerging markets
  • Excellent internal and external (regulatory authorities, distributors, customers) communication skills
  • A minimum of 4 years of medical device regulatory, quality management or clinical experience
  • Ability to independently identify compliance risks and escalate when necessary
  • Knowledge of Medical Device regulations (UK, EU, Brazil, China, US, Canada, Australia etc.)
  • Experience leading a team of professionals


  • Document handling and management systems (e.g. qpulse, LIMS, Sharepoint etc.)
  • Good time management and interpersonal skills
  • Ability to work alone and within teams to meet company needs
  • Good problem solving
  • Excellent communication skills
  • Excellent word processing skills
  • Ophthalmic product knowledge
  • Language skills