Role:Principal Regulatory SpecialistLocation:Hampshire / Hybrid roleSalary: On applicationA global company is looking to expand within the regulatory function and are looking for a talented individual to join their growing team. The type of experience is below, but do get in touch for a full job description and a confidential discussion about this role.Candidate Profile:Experience:Bachelor’s degree in a scientific or technical discipline and working knowledge of medical device regulations. Experienced at reviewing and approving product labelling. 6-8 years of medical device regulatory experience. Technical writing experience. Has experience evaluating manufacturing changes for impact on global regulatory affairs submissions. Medical device industry experience including strong working knowledge and experience with MDD and MDR. Experience in electronic document management systems Competencies:Understanding of ISO 13485 requirements and EU medical device regulations. Ability to read and understand technical material. Ability to work effectively either alone or as part of a team. Managing time effectively and completing tasks on time with general supervision. Able to work effectively in multinational/multicultural environments. Ability to build cross functional relationships as well as working collaboratively with the internal team. Confidence in communicating with people at all levels. Ability to explain complex RA requirements to stakeholders outside of the department.
