Senior Manager Regulatory Affairs

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.

The company is an international Medical Device manufacturer looking for a senior manager who is willing to grow short term to director to support the current VP.

ROLE DESCRIPTION

Manage the development, implementation, and maintenance of Regulatory strategies, registrations, submissions, and activities related to Health devices in the EMEA region.

RESPONSIBILITIES

• 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.

REQUIREMENTS

• At least a Bachelor degree with preference within a scientific field
• Working knowledge of at least 7 years in RA within a highly regulated environment
• Experience as a Manager or Director within a international environment
• Must have advanced knowledge of applicable regulations and standards.
• Ability to independently plan, execute, and/or problem solve moderate to complex situations
• Able to speak fluent English, French or Dutch is an added value

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