Head of Regulatory Affairs
Location | South East | |
Job Type | Permanent |
Overview: The Head of European Regulatory Affairs ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products. This role leads the European Regulatory Affairs team, partners with the European business, and liaises with Quality Leadership on regulatory matters.
Responsibilities
Overview:
The Head of European Regulatory Affairs ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products. This role leads the European Regulatory Affairs team, partners with the European business, and liaises with Quality Leadership on regulatory matters.
Requirements
Key Responsibilities:
- Act as the primary liaison between UK/EU management and Quality, Manufacturing, and Regulatory departments.
- Oversee the development and management of technical files, dossiers, and regulatory documents for medical devices and pharmaceuticals.
- Provide regulatory guidance and support, ensuring compliance with EU regulations, and assist in third-party audits.
- Develop and implement EU regulatory strategies, ensuring products meet all necessary requirements.
- Communicate regulatory impacts to the business and global partners, supporting global export registrations.
- Manage project assignments for investigational, new, and marketed products.
- Collaborate with R&D and Marketing to ensure product compliance in European markets.
- Liaise with government agencies and gather regulatory intelligence.
Skills & Knowledge:
- Education: Minimum of a Bachelor’s degree in life sciences, medical, or a related field.
- Experience: 8+ years in regulatory affairs, with a focus on the European market.
- Sector Knowledge: Proven experience in Medical Devices is essential, plus experience in an additional sector such as Cosmetics and/or Pharmaceuticals.
- Regulatory Expertise: In-depth knowledge of EU regulations, including MDR, MDSAP, OTC, EU Reg 1223/2009, and Quality Management Systems (ISO 22716, ISO 13485, ISO 9001).
- Leadership: Strong leadership skills with a results-oriented and business-focused approach.
- Project Management: Ability to manage multiple projects, work cross-functionally, and deliver on business goals.
- Communication: Excellent interpersonal, communication, and presentation skills, with the ability to effectively communicate across all levels within the company.
- Regulatory Interaction: Experience in dealing with regulatory authorities and working within a matrix organization.
- Language Skills: Fluency in a second language, preferably French, is a plus.
This role is crucial for ensuring regulatory compliance and supporting the company’s success in the European market.
Benefits
Salary
Bonus
Share Allowance
Car Allowance
Pension
Life Assurance
Private Medical