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Regulatory Affairs Specialist

2 months ago

Worksop, Nottinghamshire, 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. We are passionate about delivering innovative 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 the compliance of our products and processes with applicable international standards and regulatory requirements.

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 and guidance 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.
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.