Post Market Regulatory Affairs Manager
3 months ago
About the Job
Sinclair is seeking a 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. This position offers a unique opportunity to drive and enhance Post Market Regulatory processes, improving quality and efficiency throughout the organisation.
Location: Lakeside, Chester Business Park, Cheshire, CH4 9QT.
About Sinclair
Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.
This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.
Our Vision
Providing aesthetic excellence globally.
Our Mission
Driving the advancement of product quality and customer satisfaction, investing in innovation and people.
Our Values
- Act with Integrity
- Be results driven
- Embrace your winning spirit
- Stay ahead of the game
- One team, one goal
Roles and Responsibilities:
- To lead the Corporate Post Market Regulatory Affairs Team providing expert knowledge and guidance supporting the interpretation and implementation of regulatory legislation and guidelines for devices in global territories.
- Responsible for mentoring, coaching, and developing team members.
- Define performance goals and targets, conduct performance reviews, hold individual career development conversations, and regular 1:1s with team members to manage toward achieving team goals.
- To identify and participate in appropriate training events and activities to ensure personal development within the field of post market regulatory affairs.
- To identify and implement appropriate post market regulatory strategies to achieve further approvals for company's products in global territories.
- Communicate to management any changes in regulations or requirements that have been identified.
- Work with in-country distributors or contractors to determine regulatory requirements for product registrations in those regions.
- To ensure all authorisations/registrations related to established products are maintained
- Monitor pending submissions to ensure timely approvals. Communicate to management any identified delays that may impact business expectations.
- To 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.
- To 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.
- Organise consular and translation services.
- 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.
Essential:
- 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., US, Canadian regulations, APAC, LATAM, MEA, CEE/EU
- Excellent attention to detail when reviewing and preparing documentation
- Organised, target-oriented, flexible, good time management skills
- Strong written and oral communication skills
- Excellent attention to detail when reviewing and preparing documentation
- Fluency in written and spoken English
Desirable:
- Proven people leader in a regulated environment supporting regulatory teams
- Specific knowledge in dermatology/aesthetics
- Experience working with drug/device combination products
- Performance-driven critical thinker with strong business acumen
- Ability to coordinate and prioritize multiple demanding tasks in a fast-paced environment
- Ability to work effectively in a team environment and build strong working relationships.
Key Skills:
- Personal responsibility
- Communication, impact, and influence
- Analytical and critical thinking capacity
- Time management, organization, and planning
Benefits:
- 25 days annual leave (plus bank holidays)
- Bonus based on performance
- Free parking
- Opportunities for development and progression
- Company pension scheme
- Private medical insurance
- Healthcare Cash plan
- Health Screening
- 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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