Regulatory Affairs Manager

3 weeks ago

Chester, Cheshire, United Kingdom Sinclair Full time
About the Job

Sinclair is seeking a highly skilled Regulatory Affairs Manager to lead our Post Market Regulatory Affairs Team. In this role, you will oversee product market approvals in line with global regulatory standards and internal policies. You will collaborate closely with our Injectables manufacturers, Business, and Commercial teams to achieve key performance indicators and strategic goals.

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 timely provision of activities.
  • Provide regulatory advice and guidance to assist other Sinclair personnel in their roles and responsibilities.
  • Review and approve product artworks and partner marketing material according to applicable regulations.
  • Maintain submission documents, shared drive folders, and databases in an accurate, complete, and timely manner.
  • Contribute to budgeting reviews, specifically with reference to global post market regulatory requirements.
  • Manage purchase orders for global activities and invoices for relevant projects.
  • Liaise with and assist the Corporate Vigilance Team with respect to vigilance requirements of product dossiers and post marketing activities.
  • 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.
  • Support 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 organisation.
  • Working knowledge of the Medical Device Regulation.
  • Knowledge of other regulatory legislation and guidelines.
  • Organised, 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.

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