@Biocartis_

International Regulatory Specialist

Mechelen / 2016044
Contact

Biocartis NV / Email: HR@biocartis.com

Function Type
Fulltime
Experience Required

3 years’ experience with international regulatory affairs of IVDs.

FDA experience is a major asset

Education

Bachelor’s Degree in a medical, scientific or legal discipline

Functional Area
Regulatory Affairs
Travel Percentage
5-20%

 

Position within the organization

The International Regulatory Specialist will join the Biocartis Regulatory team.

 

Purpose of the position

The International Regulatory Specialist will provide the sales organization with product registration support and management of the Product Availability List (PAL).  He or she will handle the regulatory submissions for registrations in the different territories.  The Regulatory Specialist will provide regulatory review of the product labeling, promotional material and e-labeling.  He or she will provide regulatory guidance to development teams.

 

Tasks/outcome domains

  • Understand and practice the established product life cycle per USA CFR 820 and ISO 13485.
  • Have a good understanding and communication of international regulatory requirements.
  • Review product documentation, labeling and promotional materials, analyze, interpret and comment on requirements from a regulatory perspective.
  • Provide regulatory leadership to the development teams.
  • Establish and maintain regulatory plans, monitor and report progress and quality.
  • Analyze test results and communicate effectively the regulatory consequences to the rest of the development team.
  • To liaise closely with sales in support of registering product in the desired territories.
  • To liaise closely with third-party development organisations on regulatory development projects, ensuring projects are delivered to time, cost and quality objectives.
  • Maintain the Product Availability List (PAL).
  • To liaise with distributors and third party local representatives to register products in the local territories.
  • To support the regulatory compliance activities including complaint review and management of vigilance activities when needed.

 

Profile

  • Bachelor’s Degree in a medical, scientific or legal discipline;
  • At least 3 years of experience in IVD regulatory international registrations;
  • At least 2 year experience as a regulatory project lead for product development;
  • RAC Certification a plus;
  • FDA experience is a major asset;
  • Excellent English, written and spoken; other languages a plus;
  • Familiarity with qPCR, microbiology or NGS is an asset;
  • Experience in:
  • Creating, completing and maintaining regulatory plans;
  • Participating in product development or technical product reviews;
  • Creating and maintaining the PAL and Regulatory labelling reviews;  
  • Communicating effectively with both technical and non-technical personnel;
  • Quality procedures and working in a regulated IVD environment;
  • MS Office skills;
  • Time management;
  • Accuracy;
  • Achievement / Results Focused;
  • Customer Satisfaction;
  • Decision making;
  • Developing others;
  • Well-developed communication skills;
  • True team player.

     

Our offering

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.

 

Interested?

Please apply by e-mail  (Resume and motivational letter in English)  to HR@biocartis.com using the job ID 2016044 as a reference. 

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