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Senior Regulatory Affairs Specialist (IVD experience required)
Biocartis —Malines
Must be able to work effectively in a strongly matrixed team-oriented structure using excellent communication, interpersonal and relationship management skills…
3 h

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Senior Regulatory Affairs Specialist (IVD experience required)

Biocartis -
Malines

Soumettre votre candidature

Détails de l'emploi

Temps plein
Il y a 3 heures

Qualifications

Microsoft Powerpoint
Microsoft Excel
Microsoft Outlook
Systèmes PGI
Recherche
Microsoft Dynamics 365
Microsoft Office
Bachelier
Compétences en communication

Description complète du poste

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

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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Senior Regulatory Affairs Specialist

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