Senior Clinical Affairs Specialist
il y a 1 semaine
: You will be working in a team that develops clinical evaluation reports (CERs) per MEDDEV 2.7.1 Rev 4 and MDR regulations (MDCG 2020-6). Your work will support CE Mark applications, recertifications, and proposed indication/labeling changes, ensuring EU product conformance. You will also develop and review Post Market Clinical Follow-up (PMCF) strategies, participate in Risk Management assessments, and Post Market Surveillance (PMS). What you’ll do: Clinical Evaluation (35%) Develop and prepare Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) Conduct systematic literature research to support clinical evaluations and regulatory submissions Post Market clinical follow up activities (30%) Assist in the development and execution of PMCF plans and reports Collect, analyze, trend, and report on safety data Clinical Studies activities (25%) Organize and execute pre and post-market clinical trials Collaboration (10%) Collaborate with product managers, regulatory affairs managers, and other team members What you’ll need: Experience in developing Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) 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 Why you should apply: Join us to be part of a dynamic team that is at the forefront of clinical affairs. You will have the opportunity to work on innovative projects to create the next generation of our devices, ensuring compliance with changing regulations and contributing to continuous improvement activities. This role offers a chance to make a significant impact on product development and market clearance processes. You will be working in the EMEA HQ of a market leader amongst 30+ different nationalities. Home working possibilities for 2 days a week
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Product Specialist
il y a 3 semaines
Mechelen, Belgique Planet Pharma Temps pleinProduct & 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....
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Product Specialist
il y a 2 semaines
Mechelen, Belgique Planet Pharma Temps pleinProduct & 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....
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Product Specialist
il y a 3 semaines
Mechelen, Belgique Planet Pharma Temps pleinProduct & 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...
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Head of Clinical Project Management
il y a 1 semaine
Mechelen, Belgique SGS Temps pleinJob DescriptionYour MissionAs HCPM, you’ll be the driving force behind our clinical project management team. You’ll lead, coach, and empower Clinical Project Managers to deliver high-quality research projects that truly make a difference. You’ll collaborate closely with senior leadership to ensure optimal resource allocation, training, and strategic...
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Head of Clinical Project Management
il y a 1 semaine
Mechelen, Belgique SGS Temps pleinJob DescriptionYour MissionAs HCPM, you’ll be the driving force behind our clinical project management team. You’ll lead, coach, and empower Clinical Project Managers to deliver high-quality research projects that truly make a difference. You’ll collaborate closely with senior leadership to ensure optimal resource allocation, training, and strategic...
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CRA II
il y a 1 semaine
Mechelen, Belgique ICON Temps pleinCRA II Senior CRA monitor home based Belgium IPH ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical...
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CRA II
il y a 1 semaine
Mechelen, Belgique ICON Temps pleinMonitor CRA CRA II Senior CRA home based Belgium ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Senior Clinical...
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Customer Service Representative
il y a 2 semaines
Mechelen, Belgique Planet Pharma Temps pleinTitle: Customer Service RepresentativeLocation: Mechelen, Belgium - 5 days per week on-siteClient: Leading Radiopharmaceutical CompanyType: Permanent - Full-timeMain ResponsibilitiesProcess customer orders from quote to invoice accurately and on time, meeting all deadlines.Provide prompt, professional responses to customer requests and queries.Maintain and...
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Customer Service Representative
il y a 2 semaines
Mechelen, Belgique Planet Pharma Temps pleinTitle: Customer Service Representative Location: Mechelen, Belgium - 5 days per week on-site Client: Leading Radiopharmaceutical Company Type: Permanent - Full-time Main Responsibilities Process customer orders from quote to invoice accurately and on time, meeting all deadlines. Provide prompt, professional responses to customer requests and queries....
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Head of CMC
il y a 2 semaines
Mechelen, Belgique Planet Pharma Temps pleinAbout the Role We are seeking an experienced and visionary Head of CMC Development to lead and manage our Chemistry, Manufacturing, and Controls (CMC) team. This is a senior leadership role with responsibility for shaping CMC strategy, driving process development, and ensuring seamless scale-up and supply of clinical materials. The position covers small...
