Senior Clinical Affairs Specialist

il y a 18 heures


Mechelen, Belgique Science Talents Temps plein

**Introductie**:
To reinforce our client's clinical affairs team we are looking for a Senior Clinical Affairs Specialist - Medical Devices.

**Jobomschrijving**:
Clinical Evaluation (35%)
- Develop and maintain Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs)
- Perform systematic literature reviews to support clinical evaluations and regulatory submissions

Post-Market Clinical Follow-Up (30%)
- Contribute to the development and execution of Post-Market Clinical Follow-Up (PMCF) plans and reports
- Collect, analyze, and interpret safety data, including trending and reporting

Clinical Studies (25%)
- Organize and manage clinical studies for both pre-market and post-market phases
- Coordinate study activities in compliance with applicable regulations and internal procedures

Collaboration (10%)
- Work closely with product managers, regulatory affairs professionals, and other team members to support clinical and regulatory strategies

**Profiel**:

- Experience in developing Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) in medical devices
- Strong skills in conducting systematic literature research
- Ability to develop and execute PMCF plans and reports
- Proficiency in safety data analysis and reporting
- Experience in organizing and executing clinical trials
- Excellent collaboration skills with cross-functional teams
- You are fluent in English

**Aanbod**:

- Gross monthly salary starting from €4500, based on your experience and profile
- Company car or mobility budget - your choice
- Group insurance and hospitalization insurance for peace of mind
- Net expense allowance to cover professional costs
- Meal vouchers to support your daily lunch breaks
- 33 vacation days per year for a healthy work-life balance

SCIENCE2025


  • Medical Affairs Specialist

    il y a 2 semaines


    Mechelen, Belgique Biocartis Temps plein

    The Medical Affairs Specialist supports the execution of field-based medical and scientific activities within the Biocartis oncology disease portfolios. He/She acts as a key contributor connecting the medical and commercial functions by providing accurate scientific information, supporting evidence-generation activities, and facilitating knowledge exchange...

  • Medical Affairs Specialist

    il y a 2 semaines


    Mechelen, Belgique Biocartis Temps plein

    The Medical Affairs Specialist supports the execution of field-based medical and scientific activities within the Biocartis oncology disease portfolios. He/She acts as a key contributor connecting the medical and commercial functions by providing accurate scientific information, supporting evidence-generation activities, and facilitating knowledge exchange...

  • Product Specialist

    il y a 1 semaine


    Mechelen, Belgique Planet Pharma Temps plein

    Product & Marketing SpecialistAbout the roleWe are looking for a Product & Marketing Specialist to support product management, marketing activities, and public tender processes across the BENELUX region. This role blends office-based coordination with occasional field visits, ensuring smooth operations, strong customer relationships, and impactful campaigns....

  • Product Specialist

    il y a 1 semaine


    Mechelen, Belgique Planet Pharma Temps plein

    Product & Marketing SpecialistAbout the roleWe are looking for a Product & Marketing Specialist to support product management, marketing activities, and public tender processes across the BENELUX region. This role blends office-based coordination with occasional field visits, ensuring smooth operations, strong customer relationships, and impactful campaigns....

  • Product Specialist

    il y a 1 semaine


    Mechelen, Belgique Planet Pharma Temps plein

    Product & Marketing Specialist About the role We are looking for a Product & Marketing Specialist to support product management, marketing activities, and public tender processes across the BENELUX region. This role blends office-based coordination with occasional field visits, ensuring smooth operations, strong customer relationships, and impactful...

  • HR Specialist Trilingual

    il y a 17 heures


    Mechelen, Belgique HNM Solutions Temps plein

    **Job ID: HNMJD3157**: **Role**: **HR specialist trilingual** **Location**: **Mechelen** **, Belgium** **Language**: **Dutch, English,** **French** **Onsite vs remote: work** **2 days on site, 3days remote** - Do you also like an environment that thinks beyond today? - Do you get energy from working together with difference makers who challenge the status...


  • Mechelen, Belgique SGS Temps plein

    Company Description At **SGS**, you can choose! First of all, out of our various vacancies. However, SGS also gives you another choice. Do you choose to _expand_ or to _enrich_? We are not only looking for colleagues who can go in to depths of their discipline. We are equally as much looking for colleagues who we call ‘connectors’, people who can...


  • Mechelen, Belgique Findhu Temps plein

    The Senior Accountant should bring a background and experience in US GAAP, consolidation, audits, and experience with requirements (like SOX compliance). This role will be embedded in the global accounting team, reporting to the accounting manager and working closely together with the Senior BE Accountant and the Senior US...

  • Senior Corporate Accountant

    il y a 2 semaines


    Mechelen, Belgique Biocartis Temps plein

    The purpose of this role is to ensure accurate, compliant and timely corporate and group financial reporting by managing consolidation, and IFRS-related activities, leading general ledger operations, and providing expert accounting support to the Accounting Manager. The role exists to strengthen technical accounting quality, continuity, and reliability of...

  • product developer

    il y a 2 semaines


    Mechelen, Belgique WhatJobs Temps plein

    Voor een sterke speler in de chocoladesector zoeken wij een Senior R&D Product Developer. In deze sleutelrol ontwikkel je nieuwe pralines en chocoladeproducten van idee tot productie. Je vertaalt klantvragen naar creatieve concepten en zorgt ervoor dat elk detail klopt. Een rol waarin traditie en innovatie samenkomen! Senior R&D Product Developer - Regio...