Regulatory Affairs Manager
4 days ago
Job Title: Regulatory Affairs Manager - Post Market
Company: Sinclair
Location: Remote
Job Type: Full-time
Industry: Medical Devices
Job Description:
Job Summary:
Sinclair is seeking a highly skilled Regulatory Affairs Manager to lead our Post Market Regulatory Affairs Team. As a key member of our team, you will be responsible for overseeing product market approvals in line with global regulatory standards and internal policies.
Key Responsibilities:
- Oversee product market approvals in line with global regulatory standards and internal policies
- Collaborate closely with our Injectables manufacturers, Business, and Commercial teams to achieve key performance indicators and strategic goals
- Drive and enhance Post Market Regulatory processes, improving quality and efficiency throughout the organisation
- Mentor, coach, and develop team members
- Define performance goals and targets, conduct performance reviews, and hold 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
- Identify and implement appropriate post market regulatory strategies to achieve further approvals for company's products in global territories
- Work with in-country distributors or contractors to determine regulatory requirements for product registrations in those regions
- Communicate to management any 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 any 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 the applicable regulations
- Ensure maintenance of 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 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 & 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 organisation
- Working knowledge of the Medical Device Regulation
- Knowledge of other regulatory legislation and guidelines, e.g., 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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