Job Description
Blackfield are partnered with an international business with a medical device portfolio, looking to hire an an experienced Regulatory professional to lead the EU Regulatory team and manage the MDR projects.
As Head of Regulatory, you will:
* Act as the primary contact 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.
To be considered for the role of Head of Regulatory, you will have the following experience/ Skills:
* Educated to degree level in a relevant scientific field
* More than 7.5 years' experience in regulatory affairs, ideally gained within a Medical device/ consumer goods business with EU activities
* Proven experience in Medical Devices is essential, plus experience in an additional sector such as Cosmetics and/or Pharmaceuticals will be considered/ preferable
* Experience managing MDR and MDSAP requirements, along with OTC, EU Reg 1223/2009 and Quality Management Systems (ISO 22716, ISO 13485, ISO 9001).
* Proven experience managing direct reports or previously involved in career development
* Experienced managing multiple projects, work cross-functionally, and deliver on business goals.
* Due to portfolio size, only candidates who have extensive, hands on experience with either leading audits, or being key point of contact for audits and inspections by regulatory bodies.
* Language Skills: Fluency in a second language, ideally French would be highly desirable
This role is crucial for ensuring regulatory compliance and supporting the company's success in the European market. This role can be remote, with monthly visits to HQ.
There will be travel to affiliate sites in Europe several times per year.