Quality Assurance & Regulatory Specialist

• Leeds/Hybrid working
• £30,000 - £35,000 DOE + 10% bonus
• Excellent training
• Private Healthcare, 6% employer contribution to pension + more benefits.
• 25 days annual leave (+ bank holidays + birthday off)

OUR CLIENT:

Our client is a supplier and distributor of pre and post-natal products and devices. They are a house-hold name and a global leader within the industry, starting from the founders’ kitchen with the view to solve a specific need, now a multimillion-pound international brand with a wide and trusted product range. As a result of their continued success, we are now searching for a Quality Assurance & Regulatory Specialist to join their team.

THE ROLE:

Reporting into the Chief Quality and Strategy Officer, this candidate will be responsible for maintaining compliance, identifying quality concerns, developing recommendations to improve internal controls, and keeping an auditable trail of all work done to report back to the senior leadership teams.

This role will collect, organise, monitor, and distribute information related to quality and process improvements, including compliance and documentation of quality management standards (ISO9001, ISO13485 and EC1233/2009). Additionally, this role will manage and administer the updating of regulatory needs or current products, and the registration of regulatory needs of new products for the international market.

ROLES & RESPONSIBILITIES:

• Ensuring all Cosmetics, Medical Devices, OTC’s and customer goods are registered properly at the countries where responsible offices sell the products to.
• Partner with external legal counsel and consultants, understanding industry and regulatory requirements for responsible countries.
• Leverage and maintain business relationships
• Ensure all employees are complying with appropriate Quality System procedures.
• Provide regulatory guidance for registration filing strategies, policies, procedures, standards, requirements, and labelling requirements for new products as well as updating existing products.
• Represent the organisation externally as Quality assurance liaison for responsible countries.
• Facilitate new product registration as well as renewals, as required for export product sales in foreign regions (cosmetics and medical devices).
• Be primary contact for the competent authorities in each region where the UK arm of the business and Export team sells products.
• Inform business of changes or updates to regulations that may impact sale or export.
• Be main point of contact for QA/RA consultant management, assist with current regional specific requirements and registrations.
• Review and approve packaging and labelling for SKU’s outside of North America from a Quality, Regulatory, Regional Requirements, and Cohesive communication standpoint.
• Create and maintain a database and library for all product SKUs that includes the countries Registration Status/Expiration Timeframes, and Documentation used for registration (Export).

SKILLS & EXPERIENCE:

• 2+ years’ in a Quality Assurance role within the Pharmaceutical, Personal Care, Biotechnology or Medical Device industry.
• Experience with compliance with ISO9001, ISO13485, and EC1223/2009.
• Experience with regulatory labelling requirements for cosmetics and medical devices.
• Project Management or Project Team Leadership experience.
• Experience generation Process Metrics and reports.
• Ability to work within strict timelines and requirements, highly organised and analytical.
• Ability to respond to common enquiries or complaints from consumers, suppliers, and regulatory agencies.
• Ability to research and process information regarding regulatory requirements.

This is an excellent opportunity for an Quality Assurance professional to join an international yet close knit house-hold brand. If you would like to discuss the opportunity further, please contact Alice McGlaughlin on the number listed on our website. Alternatively, please apply today and we will contact you directly.

Thank you for taking an interest in the role advertised. We’d like to confirm that each CV received is read thoroughly by a trained consultant. If we have not contacted you within 5 working days of your application, please understand that the CV received, and the information provided does not meet the requirements of the role. However, if you wish to speak to the named consultant about your application, please feel free to contact us directly.