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Regulatory Affairs Manager



The Career PotentialOrtho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.Ortho is known in the industry as a leader in customer service and support.  Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do.  It’s who we are.  If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work. Regulatory Affairs ManagerAs Ortho continues to grow, we are seeking a Regulatory Affairs Manager to join our team. We are willing to consider remote working opportunities in the UK for this role, although there will be requirements to attend the Pencoed, South Wales site on occasions.About Ortho, Pencoed:Ortho Clinical Diagnostics has been manufacturing products in South Wales for over 40 years. Our state-of-the-art manufacturing facility, based in Pencoed, employs over 500 people who are involved in the manufacture and supply of clinical laboratory and immunohematology products to a global customer base. Our Pencoed team manufacture a large menu of immunoassay products encompassing a range of disease categories. In addition to the continued support our growing scientific community provide to our existing products, we are also harnessing our Research & Development capabilities for the creation of novel new content to expand our immunoassay menu. We are proud to be a global hub for critical manufacturing lines, and we have recently expanded our capabilities with three new state-of-the-art manufacturing lines to produce a comprehensive suite of immunohematology products for blood typing and crossmatching of blood donor units. On site we have a range of functions operating globally & locally. All our employees are working towards one common goal, to help save and improve lives through diagnostics. Your New Role:In your new role, your primary responsibility will be to support a team of employees of varying levels, being responsible for developing and implementing local strategies and leading of the day-to-day regulatory affairs base business operations and new product development projects within the Clin Labs, Transfusion Medicine and Donor Screening Units.What You’ll be Doing:Reviewing and interpreting regulations/guidance documents to develop regulatory strategy to support Clin Labs, Transfusion Medicine and Donor Screening project teams in terms of regulatory submission pathway, predicate device selection, submission requirements, timing, and risks.Interact with US FDA and/or International regulatory personnel (Corporate IRA and/or country RA) to define submission content, expedite pending applications, and resolve regulatory matters. Responsible for the 1 over 1 final review of critical regulatory documents planned for regulatory submissions and responses to regulatory agencies as needed.Make judgments about operational impact of proposed actions, identifies, and interacts with appropriate resources in order to successfully achieve company and regulatory strategy objectives.Reviews/ interpret product specific regulatory issues that may have material impact on the business, the corporation, or the customer; develop strategic and tactical responses to influence a reasonable and compliant regulatory environment.Represent Ortho to US regulatory agencies and interact with Health ministry personnel to expedite pending applications, resolve regulatory matters, and manage development meetings for regulatory submissions.Identify and/ or lead process improvement projects to streamline current activities and increase department efficiencies.Development goals, such as webinars, review FDA website and articles, read journals, attendance at industry meetings, to expand knowledge and skill set in Regulatory affairs. Coach, mentor junior staff.Provide guidance to business partners and junior regulatory staff regarding regulatory requirements including indications of risks and appropriate timing for approvals for planning purposes.  What You’ll Need to Succeed:Bachelor’s degree in a scientific or related discipline; or equivalent combination of education and experience.RAC (Regulatory Affairs Certification) is a plus.8 years+ of experience in a regulated Medical Device Industry required; In Vitro Diagnostic or Biologics Industry experience preferred.6+ years of experience developing and executing regulatory strategies for complex projects under product development requiring a US FDA submission (510(k), PMA and BLA preferred), CE Mark under current IVDD and IVDR requirments, Canadian Licensing and Rest of World (ROW) registrations. Previous people management experience is desired but not essential.Use or Process Excellence (PEx) tools for process improvement initiatives is a plus.Excellent interpersonal, teamwork and verbal/written communication skills are required. Good organizational skills and an ability to manage multiple tasks/projects/priorities .The ability to demonstrate model behaviour, understands priorities and encourages others to drive for results will be needed.Ability to mentor and coach junior level staff as well as cross-train with peersWhat We OfferCompetitive Base SalaryYearly Salary Reviews.Pension SchemeBonus SchemeLife AssuranceHealthcare SchemeCycle to Work Scheme25 days Holidays + 8 Bank Holidays (Milestone Increases Available)Employee Assistance ProgrammeOn-Site Gym FacilitiesSubsidised Canteen#LI-RP1#LI-RemotePlease apply through Work Day if you are interested in this opportunity. For more information, please contact Richard Pearson (Senior Recruiter [email protected]).Closing date: 18th October 2021

Full time


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