Hologic Regulatory Affairs Specialist in Belgium

Regulatory Affairs Specialist

Post Date Sep 25, 2018


Support the development, implementation, and maintenance of registrations, submissions, and activities in the EMEA region.


  • Apply regulations by supporting regulatory strategies for EMEA markets.

  • 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..

  • Review and approve advertising and promotional materials for regulatory compliance.

  • Prepare and review regulatory agency information packages and submissions.

  • Interact with regulatory agencies.

  • Assess and approve labelling, process, and procedures changes for regulatory impact and ensure maintenance of 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 impacting Hologic’s medical devices.

  • Perform other related duties as assigned.


  • Bachelor or equivalent in biological sciences, life sciences or related discipline with the required skills, knowledge and abilities that are typically acquired through a minimum of 2 years’ experience in the in vitro diagnostics, medical device or pharmaceutical industries; with at least 4 of those years in a wide breath of Regulatory roles.

  • Must have basic knowledge of applicable regulations and standards.

  • Ability to independently plan, execute, and/or problem solve moderate 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 and professionally with medical personnel

  • Ability to manage multiple projects