Regulatory Manager

Recruteur
PaHRtners
Région
Liège (Province) (BE)
Publication
mardi 31 juillet 2018
Date limite
vendredi 31 août 2018
Type de contrat
CDI
Temps de travail
Temps plein

Founded in 2016, Oncoradiomics is an innovative and ambitious start-up established in Liège. Oncoradiomics's strategic goal is to "revolutionize precision medicine”, by applying advanced artificial intelligence to clinical imaging.

Oncoradiomics focuses on tailoring cancer care to the clinical, imaging, biological and genetic characteristics of an individual patient so that the best outcome can be achieved.

Oncoradiomics holds several international grants and patents and is continuously developing and connecting with leading industrial and academic players to advance healthcare and the life sciences.

For the expansion of the team in Liège, we are looking for a (m/f):

 

Regulatory Manager

 

Responsibilities:

As a Regulatory Manager, you lead and drive the execution of Oncoradiomics global regulatory strategy. Reporting to the CEO, you define and implement the regulatory policy in line with applicable directives, guidelines and legal requirements. Your main responsibilities are:

  • You drive regulatory strategy for EU/US markets: develop global regulatory strategies and drive the international product registration activities (with focus on EU, US, Canada, Australia, Japan, China and South Korea).
  • You prepare, organize, and submit global regulatory submissions/approvals.
  • You prepare and submit regulatory filings including, CE marking, FDA clearance (e.g. traditional and special 510(k) applications), letters to file, technical files, etc.
  • You ensure regulatory requirements for establishment registrations, device listings, and registration licensing is maintained.
  • You perform MDR and MDV complaint reporting assessments.
  • You support the product development team in the implementation of regulatory requirements, including review of design input, risk management, and test documentation.
  • You perform regulatory assessment of product changes.
  • You proactively interpret regulatory guidelines and regulations, anticipate concerns, educate, and integrate requirements into product development programs.
  • You review and approve marketing materials to ensure compliance with advertising and promotional regulations.
  • You support internal and external audits.

Profile:

  • Master or PhD in life sciences or equivalent through experience.
  • 5 to 10 years experience in a RA position in the (software solutions) MedTech sector.
  • Proven track record of building strong relationships with internal and external stakeholders.
  • Ability to maintain multiple projects and meet timelines, including change management skills.
  • Client-centered and solution-oriented, with hands-on and pragmatic mindset.
  • Excellent leadership, communication and interpersonal skills.
  • Fluency in English.

Offer:

  • A challenging and diversified position within a high-potential innovative start-up company.
  • To work in a dynamic, respectful and professional environment.
  • International exposure, with learning and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.

Interested?

Please send your CV together with an adapted cover letter http://www.pahrtners.be/job/regulatory-manager/ or to recruitment@pahrtners.be

Your application and related information will remain strictly confidential.

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