Blackfield Associates are pleased to be supporting a key client, a global consumer goods company with prime portfolio across multiple categories, looking for an experienced regulatory leader to develop and lead the European strategy and guide the RA team.
In the role you will have oversight and ensure all regulatory requirements across Europe, partnering closely with the European business and liaising with various departments to achieve our strategic goals.
Key Responsibilities:
* Act as the bridge between UK/EU management and the Quality Business, QA Manufacturing, and Regulatory Departments.
* Ensure effective communication of issues, concerns, and management objectives across departments.
* Direct the development and management of regulatory documents, including technical files and dossiers.
* Provide guidance on EU regulatory strategy and compliance for medical device and pharmaceutical products.
* Lead and manage project assignments related to investigational, new, and marketed products.
* Act as a liaison with government agencies and trade associations to gather and anticipate regulatory changes
* Communicate the impact of emerging regulations to the business and global partners.
To be considered for the role of European Head of Regulatory Affairs, you will have the following skills and experience:
* Education: Minimum of a Bachelor's degree in life sciences, medical, or a related field.
* Experience: 10 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.
* Awareness: of legislation impacting the European manufacturing requirements in Cosmetic, Medical Device, Electrical, Food supplement, and Detergent sectors
* Regulatory Strategy for: MDR, MDSAP, OTC, EU Reg 1223/2009, and Quality Management Systems (ISO 22716, ISO 13485, ISO 9001).• Strong leadership skills with a focus on results and business.
* Line Management: This role requires previous leadership, with proven success in influencing and mentoring teams, ideally across multiple locations
* Experience working in a matrix, pan European organisation is essential
This is a permeant role, with hybrid working between the Kent HQ and regular visits to the European affiliate teams. A flexibility to travel is a must. This is a high visibility role with leadership responsibilities.
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