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- Tasks: Manage regulatory activities for injectable medical devices and ensure compliance with EU/CEE regulations.
- Company: Sinclair is a global leader in medical aesthetics, operating in 55 countries since 1971.
- Benefits: Enjoy 25 days annual leave, company bonuses, private medical insurance, and flexible working options.
- Why this job: Join a dynamic team focused on innovation and personal development in a fast-paced environment.
- Qualifications: 3-5 years in Regulatory Affairs; a scientific degree is a plus but not essential.
- Other info: Work in Chester or London, with opportunities for cross-functional collaboration and personal growth.
The predicted salary is between 30000 - 42000 £ per year.
We are currently recruiting for a Regulatory Affairs Specialist in the UK. The Regulatory Affairs Specialist will be responsible for regulatory activities in support of lifecycle management for injectable medical device products at Sinclair. This role 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 Specialist supports 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.
What You'll Be Doing:
- 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 and communicate 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.
- 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 the 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.
Regulatory Affairs Specialist employer: Sinclair
Contact Detail:
Sinclair Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Specialist
✨Tip Number 1
Familiarise yourself with the specific regulatory frameworks for medical devices in the EU/CEE markets. Understanding the nuances of these regulations will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with injectable medical devices. Attend industry events or webinars to make connections that could provide insights or referrals.
✨Tip Number 3
Stay updated on recent changes in regulatory legislation and guidelines. Being able to discuss current trends and how they impact Sinclair's products can set you apart during the interview process.
✨Tip Number 4
Prepare to showcase your problem-solving skills by thinking of examples where you've successfully navigated regulatory challenges in the past. This will highlight your ability to handle the responsibilities outlined in the job description.
We think you need these skills to ace Regulatory Affairs Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your 3-5 years of experience in Regulatory Affairs, specifically mentioning any relevant experience with injectable medical devices. Use keywords from the job description to demonstrate your fit for the role.
Craft a Strong Cover Letter: Write a cover letter that showcases your understanding of regulatory legislation and guidelines for medical devices. Mention how your skills align with Sinclair's values, such as integrity and results-driven focus.
Highlight Relevant Skills: In your application, emphasise your strong written and oral communication skills, attention to detail, and ability to work under pressure. These are crucial for the Regulatory Affairs Specialist role.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is essential in regulatory affairs.
How to prepare for a job interview at Sinclair
✨Know Your Regulations
Familiarise yourself with the latest EU/CEE regulatory guidelines for medical devices. Be prepared to discuss how these regulations impact Sinclair's products and demonstrate your understanding of compliance requirements.
✨Showcase Your Experience
Highlight your 3-5 years of experience in Regulatory Affairs during the interview. Prepare specific examples of past projects where you successfully managed regulatory submissions or navigated complex compliance issues.
✨Demonstrate Communication Skills
Since the role involves liaising with various stakeholders, practice articulating your thoughts clearly. Be ready to explain how you would communicate regulatory changes to management and collaborate with cross-functional teams.
✨Emphasise Attention to Detail
Given the importance of accuracy in regulatory documentation, prepare to discuss how you ensure meticulousness in your work. You might want to share examples of how your attention to detail has positively impacted previous projects.
