European Head of Regulatory Affairs
2 days ago
A key position has become available within our organization, offering a unique opportunity to lead regulatory affairs across Europe. As European Head of Regulatory Affairs, you will play a vital role in ensuring compliance with regulatory requirements and driving strategic initiatives.
About UsWe are a company that genuinely cares about our people, our products, and the environment. Our culture champions courage, determination, and collaboration, providing a supportive team where each member has the freedom to take responsibility and ownership.
United by the belief that when we strive for growth, anything is possible, we have a shared passion to work hard, innovate, and push boundaries. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.
Your Key Responsibilities:- Liaison & Communication: Act as the bridge between UK/EU management and the Quality Business, QA Manufacturing, and Regulatory Departments, ensuring effective communication of issues, concerns, and management objectives across departments.
- Regulatory Oversight: Direct the development and management of regulatory documents, including technical files and dossiers, and provide guidance on EU regulatory strategy and compliance for medical device and pharmaceutical products.
- Project & Audit Management: Organize and manage project assignments related to investigational, new, and marketed products, and assist in third-party and competent authority audits.
- Regulatory Intelligence: Act as a liaison with government agencies and trade associations to gather and anticipate regulatory changes, communicating the impact of emerging regulations to the business and global partners.
- Strong leadership skills with a focus on results and business.
- Ability to exercise sound judgment, manage multiple projects, and work cross-functionally.
- Excellent communication and presentation skills.
- Competent in dealing with regulatory authorities.
- Experience working in a matrix organization.
- Fluency in a second language (ideally French) is preferable.
The estimated annual salary range for this position is $120,000-$180,000, depending on experience and qualifications. This figure reflects the competitive market rate for similar positions in the region and takes into account the specific requirements of the job.
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