EMEA Sr Regulatory Affairs Manager

Location: Belgium

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Brussel Belgium.

Activities related to Breast and Skeletal Health devices in the EMEA region.

ROLE DESCRIPTION

- Interpret and apply regulations by creating regulatory strategies for EMEA markets.
- Define, monitor, collate, and publish deliverables for submissions in coordination with divisional BSH and EMEA marketing and sales 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.
- Interact with regulatory agencies.
- 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 impacting BSH devices. Assess impact and disseminate throughout the organization for continued regulatory compliance.
- Develop staff skills, abilities, and experiences for succession.
- Perform other related duties as assigned.

RESPONSIBILITIES

See above

REQUIREMENTS

- Bachelor or equivalent in engineering, life sciences or related discipline with the required skills, knowledge and abilities that are typically acquired through a minimum of 7 years of experience in the medical device industry; with at least 4 of those years in a wide breath of regulatory roles.
- Must have advanced knowledge of applicable regulations and standards.
- 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 and professionally with medical personnel
- Ability to manage multiple projects.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.