Regulatory Affairs Specialist

Sinclair; Chester; Hybrid; GBP 40,000 - 50,000; Full time

Job summary

Sinclair, a leading global medical aesthetics organisation, is seeking a Regulatory Affairs Specialist. The role involves managing regulatory activities for injectable medical devices, ensuring compliance with legislation while working collaboratively with both internal and external stakeholders. A great opportunity for someone with experience and a passion for regulatory affairs, offering extensive benefits and a supportive work environment.

Benefits

25 days annual leave plus bank holidays

Company bonus scheme

Free parking onsite

Company pension scheme

Private medical insurance

Healthcare Cash plan

Health Screening

Employee Assistance Programme

Store discounts

Cycle to work scheme

Qualifications

• 3-5 years' experience in Regulatory Affairs is essential.
• Good written and spoken English.
• Experience in medical devices is highly valued.

Responsibilities

• Provide expert guidance for regulatory legislation in EU/CEE markets.
• Prepare and submit regulatory applications by deadlines.
• Maintain all necessary authorisations and registrations.

Skills

Knowledge of Regulatory legislation

Communication skills

Excellent computer skills

Attention to detail

Education

University Degree in a scientific or engineering field, desired

Job description

Sinclair isHiring! Join Our Team as a Regulatory Affairs Specialist

We are currently recruiting for Regulatory Affairs Specialistin the UK. The Regulatory Affairs Specialistwill be responsible forregulatory activities in support of lifecycle management for injectable medical device products at Sinclair. This Regulatory Affairs Specialist will support a variety of responsibilities and requirements within the company to achieve agreed targets and schedules to maintain/obtain new and current authorisations/registrations for injectable medical device products. The RA Specialistsupports regional markets (EU/CEE) and is part of the RA team.

The ideal candidate will have 3-5 years experience in Regulatory Affairs

Location: 3 days a week in either our Chester or London office

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.

Sinclair Values:

Act with IntegrityConsistently doing the right thing even when it’s the hard choice; 100% Compliance with all rules, standard operating procedures and guidelines
Results-DrivenMake a business impact in all you do, whether sales, efficiency, operational excellence; it should make a meaningful impact
Innovation-CenteredRedefining Aesthetics, we must be pioneering in how we do business; this can be in products, in service models, or strategy
One Company, One GoalWorking towards unified mission, we are all Sinclair and be seen by customers as one company in every way

Own It!Be Accountable for your decisions, actions and consequences; Be Reliable to your customers and colleagues

What You'll Be Doing:

• To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines, specifically for EU/CEE markets, for Sinclair products.
• Communicate to management any changes in regulations or requirements that have been identified
• Undertake the preparation and submission of all new regulatory applications (e.g. clinical trials, registrations, renewals, variations, labelling / artwork) to agreed timelines
• Ensure all authorizations / 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
• 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
• 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
• Identify and participate in appropriate training events and activities to ensure personal development within the field of regulatory affairs
• Liaise with and assist vigilance team with respect to vigilance requirements of product dossiers and post marketing activities where necessary
• Maintain monthly business reports as necessary
• Raise purchase orders as necessary and manage invoices related to assigned work.
• Assist in maintenance of tracking spreadsheets of costs for budgeting purposes.
• Organise consular services and translation services.
• Provide technical / regulatory input to Change Control Regulatory Assessments (EU/CEE) and associated RCN / RFRI.
• Work with in-country distributors or contractors to determine regulatory requirements for product registrations in responsible regions

Your skills and experience

Essential:

• University Degree in a scientific or engineering field, desirable but not essential.
• 3-5 years’ experience in Regulatory Affairs
• Good in written and spoken English and regional languages as applicable.
• Knowledge of Regulatory legislation and guidelines for medical devices.
• Excellent computer and administration skills.
• Experience of working in an office environment and with both internal and external suppliers/customers.

Desirable:

• Specific knowledge in dermatology/aesthetics
• Working knowledge of Pharmaceutical and Biologic Regulations
• Performance-driven critical thinker
• 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

What We're Looking For:

• Well-organised, target-orientated and flexible.
• Ability to work under pressure to tight deadlines in a multidisciplinary environment.
• Ability to complete work with minimal supervision.
• Strong written and oral communication skills.
• Management of confidential information.
• Excellent attention to detail when reviewing and preparing documentation.
• Ability to support project teams and management
• Establish and maintain relationships with local affiliates and partners

• Orientation towards achievement
• Adaptability and openness to change
• Ability to mentor and learn
• Integrity and professional ethics
• Cross-disciplinary cooperation

Perks & Benefits:

25 days annual leave (plus bank holidays)

Company bonus scheme

Free parking onsite

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

We have a real focus on developing our people, and by fostering an entrepreneurial culture, we encourage flexibility, accountability and autonomy. The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.

This is an exciting opportunity to join a successful company, with big ambitions for the future.

If this sounds like you and you meet the requirements, please apply, we would love to hear from you.

Please note if we receive a high volume of applications, we may close the role before the closing date noted.

By making this application you give consent for personal information to be used in automated decision-making processes relating to key job requirements which are stated in this ad.

Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies. Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void