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Regulatory Affairs Manager

2 months ago

Chester, Cheshire, United Kingdom Sinclair Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to lead our Post Market Regulatory Affairs Team at Sinclair. As a key member of our organization, you will be responsible for overseeing product market approvals in line with global regulatory standards and internal policies.

Key Responsibilities
  • Lead the Corporate Post Market Regulatory Affairs Team, providing expert knowledge and guidance on regulatory legislation and guidelines for devices in global territories.
  • Mentor, coach, and develop team members, defining performance goals and targets, conducting performance reviews, and holding individual career development conversations.
  • Identify and participate in appropriate training events and activities to ensure personal development within the field of post market regulatory affairs.
  • Develop and implement post market regulatory strategies to achieve further approvals for company products in global territories.
  • Work with in-country distributors or contractors to determine regulatory requirements for product registrations in those regions.
  • Communicate with management on identified delays that may impact business expectations.
  • Interact with regulatory consultants, regulatory and trade associates, and other third-party service providers to ensure their provision of requested activities to agreed timescales.
  • Provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilities.
  • Review and approve product artworks and partner marketing material according to applicable regulations.
  • Maintain all submission documents, shared drive folders, and databases in an accurate, complete, and timely manner to ensure prompt and accurate access to company regulatory information.
  • Input into budgeting review specifically with reference to global post market regulatory requirements.
  • Ensure purchase orders for global activities are raised as necessary and manage invoices for relevant projects.
  • Maintain monthly business reports as necessary.
  • Liaise with and assist the Corporate Vigilance Team with respect to vigilance requirements of product dossiers and post marketing activities where necessary.
  • Facilitate agreement between Sinclair Pharmaceuticals Ltd Legal and in-market partners regarding PoA/LoA expectations.
  • Provide technical/regulatory input to Change Control Post Market Regulatory Assessments (RoW) and associated RCN/RFRI.
  • Ensure preparation and maintenance of local market Site/Plant Master Files (SMF/PMF) for Sinclair affiliate sites.
  • Provide Post Market Regulatory support to the global EU MDR Strategy to ensure post market activities are planned and executed as part of the implementation processes.
Requirements
  • University Degree in a scientific field.
  • Minimum 6 years' experience in Post Market Regulatory Affairs Management within a Medical Device or Aesthetics organization.
  • Working knowledge of the Medical Device Regulation.
  • Knowledge of other regulatory legislation and guidelines, e.g., Organized, target-oriented, flexible, good time management skills.
  • Fluency in written and spoken English.
What We Offer
  • 25 days annual leave (plus bank holidays).
  • Bonus based on performance.
  • Free parking.
  • Company pension scheme.
  • Private medical insurance.
  • Healthcare Cash plan.
  • Employee Assistance Programme.
  • Store discounts.
  • Tech and Cycle Scheme.
  • Discounted dining card.
  • Cycle to work scheme.
  • Green car scheme.
  • Holiday buy and sell.
  • Life Assurance scheme.