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Regulatory Affairs Specialist

2 months ago

Chorley, Lancashire, United Kingdom Vernacare International Full time
Job Title: Regulatory Affairs Specialist

Vernacare International is a leading provider of sustainable infection prevention, clinical waste management, and surgical solutions. Our team is passionate about delivering high-quality products that improve the lives of patients, residents, and healthcare professionals globally.

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with international standards and regulatory requirements for cosmetics, general products, medical devices, and pharmaceuticals.

Key Responsibilities
  • Support the Senior Regulatory Affairs Specialist and Head of QARA in ensuring regulatory compliance of products and processes.
  • Act as a point of contact for regulatory affairs, providing advice as necessary.
  • Review and interpret regulatory requirements and guidelines to ensure compliance of cosmetic product formulations, labeling, and marketing materials.
  • Coordinate with cross-functional teams to ensure regulatory compliance throughout product development and commercialization processes.
  • Prepare and submit regulatory documentation to regulatory agencies as needed.
  • Manage regulatory submissions and communications with regulatory agencies to obtain approvals and maintain compliance.
  • 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.
Requirements
  • 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.
  • Experience of Cosmetic Regulations.
  • Knowledge of Regulatory Submission preparation in key markets.
  • Experience of working with notified bodies and Regulatory Agencies.
  • Experience of pharmaceutical regulations.
  • PC experience, as well as working familiarity of desktop applications including Excel, Word, PowerPoint.
  • Good strong presentation and project management skills.
  • Risk Management.
  • Able to adopt a flexible approach to work.
  • Good planning and organisational skills.
  • Produce high standards/quality work.
  • Fluency in English.
  • Will to work flexible hours if the need arises.
What We Offer
  • Competitive Salary.
  • Hybrid Working.
  • 25 Days Annual Leave + 8 Bank Holidays.
  • Company Pension.
  • Life Insurance (4* Salary).
  • Employee Assistance Programme (EAP).
  • Refer a Friend (Up to £1,000 payment).
  • Free Onsite Parking.
  • Free Tea / Coffee.
  • Cycle to Work.
Ability to Commute/Relocate

Chorley: reliably commute or plan to relocate before starting work (required)