Regulatory Affairs Specialist

From £1 to £1 per annum Plus bonus, pension, healthcare, life assuranc
14 Oct 2016
24 Oct 2016
Contract Type
Senior Regulatory Affairs Specialist - EMEA Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments. As a result of our continuing growth, we now have an immediate requirement for a Senior Regulatory Affairs Specialist – EMEA to join our business on a Permanent basis . Duties & Responsibilities • Define, monitor, collate, and publish deliverables for submissions in coordination with divisional RA teams • Participate in regulatory submission teams • Write and/or edit submission documents using regulatory templates, or create new templates • Participate on manufacturing transfer teams as regulatory representative • Review and approve advertising and promotional materials for regulatory compliance • Ensure health hazard assessments are performed for regulatory reporting of product problems • Prepare and review regulatory agency information packages and submissions • Participate in Material Review Board and complaint/recall meetings • Assess and approve labelling, process, and procedures changes for regulatory impact and ensure maintenance of regulatory compliance • Provide recommendations on labelling, manufacturing, analytical, and clinical study plans for regulatory compliance • Advise and guide management and other personnel in other departments on the interpretation and application of regulations • Maintain current knowledge of current and proposed regulations, laws, guidelines standards, and initiatives. • Perform other related duties as assigned by the Manager, Regulatory Affairs EMEA. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required: Skills/Competencies: • Influencing skills. • Leadership skills. • Technical knowledge. • Planning and Organizational skills. • Ability to independently plan, execute, and/or problem solve moderate to complex situations. • Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. • Must demonstrate initiative, balanced assertiveness working as a team player. • Solid oral and written communication skills with ability to communicate effectively • Computer literate: strong working knowledge of word processing; familiarity with spreadsheet programs and other related programs. (Agile/Visio/Project/Oracle) • Excellent ability to read, analyse and interpret technical documents, professional journals, technical procedures and government regulations. • Excellent writing skills with ability to write detailed information for submissions. • Good presentation skills. • Good interpersonal skills to interact with all levels of the company, sometimes in an adversary role. Education • BA or BS Degree or equivalent in biological sciences, life sciences, engineering or related discipline. Experience • Minimum 5 year experience supporting regulatory activities for IVD’s/medical devices. Specialized Knowledge • Excellent working knowledge of medical device regulations (21CFR) and FDA law. • Good working knowledge of requirements for Medical Device Directives, 510(k)s, PMAs and IDEs. • Experience in supporting international registrations essential. • Certified regulatory affairs professional would be desirable. There has never been a more exciting time to join us. Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful. Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare. We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future. Agency And Third Party Recruiter Notice Agencies that submit a resume to Hologic must have a current, executed Hologic Agency Agreement signed by a member of the Talent Acquisition Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent via the Hologic Taleo portal, under these terms or they will not be considered and be will wholly owned by Hologic.” This job was originally posted as