Hologic Regulatory Affairs Specialist in Belgium

Regulatory Affairs Specialist

Post Date Sep 25, 2018

JOB SUMMARY

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

ROLE ESSENTIAL DUTIES AND RESPONSIBILITIES

  • 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.

EDUCATION AND EXPERIENCE

  • 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