Senior Regulatory Affairs Specialist (IVD experience required)

Publication date
8 June 2026
Department
Quality, Regulatory and Clinical Affairs
Country
Belgium
Location
Mechelen, Belgium (hybrid) or Europe based (remote)
Work arrangement
Hybrid
Travel percentage
10%
Function type
Full\-time
Contract type
Employee
Experience required

• Min. 5 years of experience in Regulatory Affairs;


• IVD/medical device experience preferred, especially PCR or software experience


• Must have highly effective organizational and planning skills to apply daily in a multidisciplinary environment


• Must be able to work effectively in a strongly matrixed team\-oriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Clinical, Research and Development, Manufacturing, Quality, Marketing, Operations and corporate partner counterparts


• Regulatory Affairs Certification is a plus

Proven experience with:

• In\-vitro diagnostics validation requirements and regulations; global regulatory understanding is preferred


• Ability to read, analyze and interpret complex data and review technical documents


• Excellent written and oral communication skills


• Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency

Education
Bachelor’s degree with preference for scientific, engineering or legal studies or equivalent through experience and/or training

Senior Regulatory Affairs Specialist
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The Senior Regulatory Affairs Specialist is responsible for creating and executing the regulatory plans for Biocartis’ diagnostic development programs and securing timely marketing authorizations according to agreed\-upon plans. The Senior Regulatory Affairs Specialist will support communications with regulatory authorities, including submissions, product registrations, and execution of any post market commitments as required.

Accountabilities

• + Create regulatory strategy to efficiently obtain regulatory approvals for Biocartis’ products including those for Companion/Complementary Diagnostic use

+ Communications with local and international authorized representatives and regulatory authorities
+ Work closely with R\&D teams to implement development efforts compliant to the IVDR, US 21 CFR 820, and global regulatory requirements
+ Work with Clinical Affairs to create clinical validation strategies to meet regulatory requirements
+ Review and edit technical documentation including:

• Product Validation Protocols and Reports


• Software documentation


• Risk Management documentation

+ Compile and Write regulatory submissions including but not limited to EU Technical Documentation, FDA Pre\-submission documents, IDE applications, pre\-market notifications/applications and post\-market reporting
+ Conduct regulatory intelligence/research to assist in formulation of regulatory plans
+ Review product complaints for compliance to vigilance procedures
+ Participate in periodic post market product data analysis processes; ensure post\-market reporting requirements are met
+ Monitor regulatory requirements in various markets to ensure preparedness for upcoming changes
+ Participate in regulatory audits/internal audits and inspections as appropriate

Profile requirements

• Bachelor’s degree with preference for scientific, engineering or legal studies or equivalent through experience or training;


• Min. 5 years of experience in Regulatory Affairs;


• IVD/medical device experience preferred, especially PCR or software experience;


• Must have highly effective organizational and planning skills to apply daily in a multidisciplinary environment;


• Must be able to work effectively in a strongly matrixed team\-oriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Clinical, Research and Development, Manufacturing, Quality, Marketing, Operations and corporate partner counterparts;


• Regulatory Affairs Certification is a plus;


• Proven experience with:

+ In\-vitro diagnostics validation requirements and regulations; global regulatory understanding is preferred;
+ Ability to read, analyze and interpret complex data and review technical documents;
+ Excellent written and oral communication skills;
+ Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency;

• Legislation and regulation:

+ US CFR Title 21 (applicable sections)
+ IVDD \& pending IVDR
+ GDPR
+ Various Market regulations, as assigned

• PC skills:

+ Applied knowledge of MS office (Outlook, Excel, Word, PowerPoint)
+ Applied knowledge of an ERP system, preferably Microsoft Dynamics AX

• Languages: fluent English, written and spoken

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 which includes a Flexible Income Plan.

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