Senior Regulatory Affairs Specialist

2 weeks ago

Chester, United Kingdom Consult Full time

A fantastic opportunity has presented itself to join a globally renowned 'pure play’ Aesthetic Company. Due to the rapid growth of this business, our client are seeking a self-motivated, driven Pre-Market Senior Regulatory Affairs Specialist to join theirteam in Chester. This establishment has a portfolio of differentiated, complementary aesthetic technologies with a focus on collagen stimulation. Their products are experiencing significant growth as they target clinical demand for effective, high quality,longer duration, natural-looking & mínimally invasive treatments.

**Responsibilities**:

- To provide expert knowledge and guidance concerning the interpretation and implementation of regulatory legislation and guidelines for devices, particularly in EU, US, UK, and Canadian territories.
- Preparation of technical documentation and submission packages (STEDs) for the filing of premarket global regulatory submissions in line with company strategy.
- Establish and maintain regulatory information systems, technical documentation files and routine reports.
- Collaborate with global Regulatory Affairs teams to understand existing and/or new regulatory requirements/guidelines and standards as they relate to company products and procedures
- Ensure regulatory compliance to global requirements and company policies
- Support new product development activities
- Review documents and product changes for regulatory submission impact
- To provide relevant regulatory advice and guidance to assist other personnel in the performance of their roles and responsibilities
- Review and approve product artworks and relevant marketing materials according to strategies and any applicable regulatory requirements or standard
- To identify, deliver 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 requirements of product dossiers and relevant post marketing activities as and where necessary
- Maintain monthly business reports as and where necessary

**About You**:

- Minimum 5 years’ experience in Regulatory Affairs within a Medical Device or Aesthetics organisation
- Working knowledge of the Medical Device Regulation and Medical Device Directive
- Knowledge of other regulatory legislation and guidelines, e.g., US, Canadian regulations
- University Degree in a scientific field
- Experience working with drug/device combination products
- Specific knowledge of active devices and associated standards (e.g., IEC 60601/IEC 62304)
- Specific knowledge in dermatology/aesthetics
- Strong written and oral communication skills
- Excellent attention to detail when reviewing and preparing documentation
- Fluency in written and spoken English Desirable

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