Job Description
We are seeking an experienced Regulatory Affairs Director to lead our EU Regulatory team and manage MDR projects for our international business with a medical device portfolio.
* The primary contact between management and Quality, Manufacturing, and Regulatory departments will be responsible for overseeing technical files, dossiers, and regulatory documents for medical devices and pharmaceuticals.
* The successful candidate will provide regulatory guidance, ensure EU compliance, and assist in third-party audits.
* This role involves developing and implementing EU regulatory strategies, ensuring products meet all necessary requirements.
* The Regulatory Affairs Director will communicate regulatory impacts to the business and global partners, supporting global export registrations.
* They will manage project assignments for investigational, new, and marketed products.
* Collaboration with R&D and Marketing is essential to ensure product compliance in European markets.
* Liaising with government agencies and gathering regulatory intelligence are key aspects of this role.
Requirements
* An educated degree in a relevant scientific field is required.
* The ideal candidate will have more than 7.5 years' experience in regulatory affairs, preferably in a Medical device/consumer goods business with EU activities.
* Proven experience in Medical Devices is essential, with experience in an additional sector such as Cosmetics and/or Pharmaceuticals being 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) is a must.
* The successful candidate will have proven experience managing direct reports or career development.
* Ability to manage multiple projects, work cross-functionally, and deliver on business goals is essential.
* Extensive experience leading audits, being a key point of contact for audits, or managing regulatory inspections is required.
* Fluency in a second language, ideally French, is highly desirable.
About the Role
This role is crucial for ensuring regulatory compliance and supporting the company's success in the European market.
The Regulatory Affairs Director will work remotely with monthly visits to HQ, requiring travel to affiliate sites in Europe several times per year.