Regulatory Affairs Specialist

**Job Title: Regulatory Affairs Specialist**

**Company/Division: Vernacare International**

**Location: Chorley**

**Company Description**

Vernacare are passionate about delivering sustainable Infection Prevention, Clinical Waste Management, and Surgical Solutions.

As pioneers of solutions for healthcare environments, we have a proven history of developing products that have helped improve the lives of patients, residents, and healthcare professionals globally.

With 5 manufacturing facilities across England and Wales, we provide sustainable, reliable manufacturing and pride ourselves on our heritage in British manufacturing.

**Role Description**

The primary responsibilities of the position are to support the Senior Regulatory Affairs Specialist and Head of QARA in ensuring regulatory compliance of products and processes in accordance with the applicable International Standards and Regulatory requirements for Cosmetics, General products, Medical Devices and Pharmaceuticals.

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**Principal Accountabilities**
- Act as a Point of Contact for Regulatory Affairs, providing advice as necessary.
- Creation and update of Product Files in accordance with the established schedule and requirements of international standards, regulations, and directives. Stay up to date on global cosmetic regulations, including FDA, EU, and other relevant regulatory bodies.
- Review and interpret regulatory requirements and guidelines to ensure compliance of cosmetic product formulations, labeling, and marketing materials.
- Coordinate with cross-functional teams including R&D, manufacturing, marketing, and quality assurance to ensure regulatory compliance throughout product development and commercialization processes.
- Prepare and submit regulatory documentation such as ingredient lists, cosmetic notifications, safety assessments, and labeling requirements to regulatory agencies as needed.
- Manage regulatory submissions and communications with regulatory agencies to obtain approvals and maintain compliance for cosmetic products.
- Conduct regulatory assessments for new product formulations, including ingredient safety evaluations and risk assessments.
- Provide regulatory guidance and support to internal teams on matters related to product development, labeling, and marketing claims.
- Monitor and assess changes in cosmetic regulations and proactively communicate potential impacts to the organization.
- Participate in internal and external audits to ensure compliance with regulatory requirements and standards.
- Maintain accurate and up-to-date regulatory files and documentation for cosmetic products.
- In conjunction with the QA team, support the Post Market Surveillance and Vigilance processes to ensure all regulatory and compliance requirements are met for cosmetics, medical devices, pharmaceuticals and General.

**Qualifications, Skills and Experience**
- Educated to HNC/HND level in a relevant scientific field.
- Demonstrated evidence of continuing professional development and training.
- A minimum of 3 years’ practical experience in Regulatory Affairs in the Medical Device Industry working to applicable European and International standards (e.g. ISO 13485 and ISO 14971).
- Experience of Cosmetic Regulations.
- Knowledge of Regulatory Submission preparation in key markets (e.g. EU, USA, Canada, rest of the world).
- Experience of working with notified bodies and Regulatory Agencies.
- Experience of pharmaceutical regulations
- Good strong presentation and project management skills.
- Post-Market Surveillance and Vigilance processes.
- Risk Management
- Brexit Requirements.
- Ability to work in a team environment.
- Adopt a flexible approach to work.
- Influence and facilitate problem solving and decision-making processes.
- Good planning and organisational skills.
- Ability to work well under pressure and to tight deadlines.
- Excellent attention to detail.
- Produce high standards/quality work.
- Fluency in English.
- Must be willing to work flexible hours if the need arises.

**This is a summary of the key tasks and responsibilities and is not intended to be an exhaustive list. The job may change over time to reflect the changing needs of the organisation, as well as the personal development of the post holder.**

**Benefits**:

- Competitive Salary
- Hybrid Working
- 25 Days Annual Leave + 8 Bank Holidays
- Company Pension
- Life Insurance (4* Salary)
- Employee Assistance Programme (EAP)
- Staff Forum
- Refer a Friend (Up to £1,000 payment)
- Free Onsite Parking
- Free Tea / Coffee
- Cycle to Work

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**Job Types**: Full-time, Permanent

Pay: Up to £40,000.00 per year

**Benefits**:

- Bereavement leave
- Company pension
- Cycle to work scheme
- Free parking
- Life insurance
- On-site parking
- Private medical insurance
- Referral programme
- Sick pay
- Work from home

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Chorley: r