Regulatory Affairs Expert
4 weken geleden
Careers that Change Lives
At Medtronic, we're seeking a passionate and innovative professional to collaborate with subject matter experts and project/process improvement colleagues. Our dynamic and energetic team values creativity, efficiency, and excellence. If you're eager to blend your skills with a team and drive impactful change within a collaborative environment, we want to hear from you.
We're looking for a QRA professional with a solid understanding of the MDR and a knack for navigating complex matrix QA structures. Your contribution will be pivotal in ensuring compliance. The ideal candidate will also show a keen interest in process improvements, contributing to the continuous enhancement of our operations.
A Day in the Life (Initially)
• Review and enhance QA structure: Conduct a thorough review of existing MDR QA regional structures, identifying areas for improvement, and implementing enhancements.
• Review and enhance the risk management plan for Economic Operators, identifying potential risks and mitigations.
• Coordinate with cross-functional stakeholders to gather necessary information, provide regulatory guidance, and ensure alignment on project timelines and requirements.
• Maintain comprehensive documentation and evidence to support audit defensibility, ensuring that processes and procedures can withstand regulatory scrutiny and audits.
Must Haves
• Solid understanding of the Medical Device Regulation (MDR)
• Systems agility
• Ability to navigate complex QA matrix structures
• Experience in a similar industry or related field
• Action-oriented
• Solid command of English
• Excellent communication and interpersonal skills
• Flexibility and adaptability in a fast-paced environment
• Ability to work independently and take initiative
Nice to Haves
• Knowledge of other regulatory requirements
• Proficiency with relevant software and tools
• Familiarity with agile methodologies or other project management frameworks
We Offer
We offer a competitive salary and benefits package to all our employees:
• Flexible working environment
• Annual Incentive Plan % depending on company results
• Pension scheme and group discount on healthcare insurance
• Training possibilities via Cornerstone/Skills Lab
• Employee Assistance Program and Recognize (our global recognition program)
Our Commitment
Our commitment to inclusion, diversity, and equity means zero barriers to opportunity within Medtronic and a culture where all employees belong, are respected, and feel valued for who they are and the life experiences they contribute. We know equity starts beyond our workplace, and we must play a role in addressing systemic inequities in our communities if we hope to have long-term sustainable impact.
-
Regulatory Affairs Expert
2 weken geleden
Maastricht, Limburg, Nederland Medtronic VoltijdCareers that Change LivesMedtronic is seeking a highly motivated and experienced Regulatory Affairs Specialist to join our dynamic team. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.A Day in the Life• Review and enhance QA structures to ensure compliance with MDR regulations•...
-
Regulatory Affairs Specialist
1 maand geleden
Maastricht, Limburg, Nederland Medtronic VoltijdTransformative Career OpportunityWe're seeking a highly skilled and innovative Regulatory Affairs Specialist to join our dynamic team at Medtronic. As a key member of our team, you will play a pivotal role in ensuring compliance with regulatory requirements and driving process improvements.About the RoleAs a Regulatory Affairs Specialist, you will be...
-
Regulatory Affairs Expert
4 weken geleden
Maastricht, Limburg, Nederland Medtronic VoltijdCareers that Change LivesAre you ready to collaborate with a dynamic and energetic team? We're seeking a passionate and innovative professional to join us, and work with both subject matter experts (SMEs) and seasoned project/process improvement colleagues. In our small but mighty team, your ideas and contributions won't just be heard—they'll drive...
-
Maastricht, Limburg, Nederland Merit Medical Systems Inc VoltijdAt Merit Medical Systems Inc., we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This position is responsible for ensuring regulatory compliance for assigned countries as Merit evolves, with a primary focus on the GCC region.Key ResponsibilitiesDetermine global regulatory pathways for various projects, including product...
-
Regulatory Affairs Specialist
4 dagen geleden
Maastricht, Limburg, Nederland Merit Medical Systems Inc VoltijdOverviewMerit Medical Systems, Inc. is a dynamic and innovative company with a strong global presence.About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Saudi Arabia. This role will be responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level,...
-
Regulatory Affairs Expert
3 weken geleden
Maastricht, Limburg, Nederland Medtronic VoltijdCareers that Change LivesMedtronic is seeking a highly skilled and innovative professional to join our dynamic and energetic team. We are looking for a QRA specialist with a solid understanding of the MDR and a knack for navigating complex matrix QA structures.A Day in the Life• Review and enhance QA structure: Conduct a thorough review of existing MDR QA...
-
Regulatory Affairs Expert
6 dagen geleden
Maastricht, Limburg, Nederland Merit Medical Systems Inc VoltijdJob DescriptionThis is a senior-level role responsible for ensuring regulatory compliance and managing global regulatory submissions for Merit Medical Systems, Inc.Key ResponsibilitiesDetermine global regulatory pathways for various projects, including product classification and type of regulatory submission or rationale required.Participate on various teams...
-
Regulatory Affairs Specialist
4 weken geleden
Maastricht, Limburg, Nederland Merit Medical Systems Inc VoltijdJob SummaryThis role is responsible for ensuring regulatory compliance for assigned countries as Merit evolves. The position will be based in Saudi Arabia and involves coordinating, preparing, and maintaining regulatory submissions and documents on a global level.Key ResponsibilitiesDetermines global regulatory pathways for various projects, including...
-
Senior Regulatory Affairs Specialist
1 maand geleden
Maastricht, Limburg, Nederland Merit Medical Systems Inc VoltijdJob SummaryThis position is responsible for ensuring regulatory compliance for assigned countries as Merit evolves. The successful candidate will coordinate, prepare, and maintain regulatory submissions and documents on a global level, with a focus on the Saudi Arabia and GCC region.Key ResponsibilitiesDetermine global regulatory pathways for various...
-
Regulatory Affairs Specialist
4 weken geleden
Maastricht, Limburg, Nederland Merit Medical Systems Inc VoltijdJob SummaryThis role is responsible for ensuring regulatory compliance for assigned countries as Merit evolves. The position will be based in Saudi Arabia and will involve coordinating, preparing, and maintaining regulatory submissions and documents on a global level.Key ResponsibilitiesDetermines global regulatory pathways for various projects, including...
-
Regulatory Affairs Expert for Medical Device Compliance
19 uur geleden
Maastricht, Limburg, Nederland Medtronic VoltijdMedtronic is a dynamic and energetic company seeking a passionate and innovative professional to join our team. This role requires collaboration with subject matter experts and seasoned project/process improvement colleagues to drive meaningful change and growth.We are looking for a QRA professional with in-depth understanding of the MDR and experience...
-
Digital Solution Architect
4 weken geleden
Maastricht, Limburg, Nederland DSM VoltijdProduct Domain Architect and Digital StrategistWe are seeking a highly skilled Product Domain Architect and Digital Strategist to join our team at DSM. As a key member of our digital architecture team, you will play a vital role in shaping the future of our company.Your Key Responsibilities:Define and communicate the technology landscape for the Product...
-
Clinical Research Specialist
3 weken geleden
Maastricht, Limburg, Nederland Medtronic VoltijdUnlock Your Potential in Clinical Research!Medtronic is seeking a highly skilled Clinical Research Specialist to conduct clinical studies in compliance with regulatory standards and align with business needs. As a key member of our team, you will monitor progress and results of clinical investigations, prepare clinical trial budgets, and oversee operational...
-
Digital Solution Architect
1 maand geleden
Maastricht, Limburg, Nederland DSM VoltijdUnlock the Future of Product DevelopmentAs a Digital Solution Architect at DSM, you will play a vital role in shaping the future of our company's product domain. You will collaborate closely with our digital architecture team to drive the development of strategic plans that encompass people, processes, technology, and data.Your Key Responsibilities:Define...
-
Senior Consultant Omgevingsbeheer
4 weken geleden
Maastricht, Limburg, Nederland SABIC - Saudi Basic Industries Corp. VoltijdFunctiebeschrijvingDe Senior Adviseur Omgevingsbeheer maakt deel uit van de afdeling Third Party Affairs (TPA) binnen PPS-Pipelines. Het TPA-team stelt alles in het werk om verstoringen in het pijpleidingtransport door activiteiten van derden te voorkomen en in het behouden van een ongestoorde ligging. Binnen de afdeling zijn urban planners, pipeline...
-
Senior Statistician
4 weken geleden
Maastricht, Limburg, Nederland Medtronic VoltijdCareers that Change LivesThe lifesaving work of medical professionals inspires us. Through partnerships with medical communities around the globe, we create advances in medical devices, supplies, and products to improve lives. From reducing surgery time to accelerating healing, our breakthrough solutions are a vital part of daily healthcare delivery. Through...
-
Customer Support Specialist Benelux
2 weken geleden
Maastricht, Limburg, Nederland Bayer VoltijdCompany OverviewBayer is a modern employer that takes care of its employees and helps them find a balance between career development opportunities and personal life planning. Our company strives to hire the best, most talented people from around the world and work to keep our employees as long as possible.SalaryWe offer a competitive gross monthly salary...
-
Treasury Internship Opportunity
4 weken geleden
Maastricht, Limburg, Nederland DSM VoltijdUnlock Your Potential in Treasury OperationsAre you passionate about corporate finance and capital markets? Do you have an analytical mind eager to dive into the complexities of internal financing? At DSM, we're offering a unique internship opportunity in Internal Financing, where you can contribute to optimizing our financing structures and gain invaluable...
-
Senior Biostatistician
4 weken geleden
Maastricht, Limburg, Nederland Medtronic VoltijdCareers that Change LivesThe lifesaving work of medical professionals inspires us. Through partnerships with medical communities around the globe, we create advances in medical devices, supplies, and products to improve lives. From reducing surgery time to accelerating healing, our breakthrough solutions are a vital part of daily healthcare delivery. Through...
-
Senior Regulatory Affairs Specialist.
5 maanden geleden
Maastricht, Nederland Medtronic VoltijdCareers that Change Lives Are you ready to join a dynamic and energetic team? We're seeking a passionate and innovative professional to join us, and collaborate with both subject matter experts (SMEs) and seasoned project/process improvement colleagues. In our small but mighty team, your ideas and contributions won't just be heard—they'll drive...
-
Senior Regulatory Affairs Specialist
6 maanden geleden
Maastricht, Nederland Merit Medical Systems Inc VoltijdJob Description SUMMARY OF DUTIES This position is responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level, for Saudi Arabia and GCC region. Primary responsibilities are to ensure regulatory compliance for assigned countries as Merit evolves. Other responsibilities include product life cycle...
-
Administrative Support
3 weken geleden
Maastricht, Nederland EUROCONTROL - Supporting European Aviation Voltijd**Function title**: Administrative Support - **Reference**: NOC-MA-2024-FGII/852 - **Location**: Maastricht - **Nature of the competition**: Internal and external competition - **Applicable regulations**: Conditions of Employment of Contract Staff at EUROCONTROL assigned at the Maastricht Centre - **Function group**: Function group II - **Job level**: 4-7 -...
-
Digital Solution Architect
6 maanden geleden
Maastricht, Nederland DSM VoltijdDigital Solution Architect - Product Domain Maastricht, Netherlands Hybrid Join the digital architecture team of dsm-firmenich, where we don't just see the future - we create it. As a Digital Solution Architect, you'll be a vital part of our diverse digital workforce, driving the development of strategic plans that encompass people, processes, technology,...
-
Digital Solution Architect
6 maanden geleden
Maastricht, Nederland DSM VoltijdDigital Solution Architect - Product Domain Maastricht, Netherlands Hybrid Join the digital architecture team of dsm-firmenich, where we don't just see the future - we create it. As a Digital Solution Architect, you'll be a vital part of our diverse digital workforce, driving the development of strategic plans that encompass people, processes,...
-
Senior Financial Accountant Maastricht-Airport
1 maand geleden
Maastricht Airport, Nederland Independent Recruiters VoltijdSenior GL Accountant Maastricht-Airport Job DescriptionWe are seeking a highly skilled financial and accounting professional to join our team as a Senior GL Accountant in Maastricht-Airport. As a key member of our General Ledger Team, you will play a crucial role in ensuring the accuracy and timeliness of our financial operations.Key Responsibilities:Prepare...
-
Intern - Treasury
2 maanden geleden
Maastricht, Nederland DSM VoltijdAre you passionate about corporate finance and capital markets? Do you have an analytical mind eager to dive into the complexities of internal financing? dsm-firmenich is offering a unique internship opportunity in Internal Financing, where you can contribute to optimizing our financing structures and gain invaluable experience in the treasury...
-
Adi Principal Test Lead
6 dagen geleden
Maastricht, Nederland Bayer Voltijd**ADI Principal Test Lead** As the ADI Principal Test Lead, you will be responsible for the software verification and validation of our class II and higher regulated AI/non-AI Software as a Medical Device (SaMD) products. You will guide and support junior and external Quality Assurance Engineers while driving process improvements in the software quality...
-
Financial Controller Central Eastern Europe
1 maand geleden
Maastricht, Nederland DSM Voltijd**Location**: Maastricht (Netherlands) **Job model**: Hybrid **Contract Duration**: 1 year Are you a financial expert with a passion for excellence and innovation? Do you thrive in dynamic environments and enjoy working with diverse teams across multiple regions? If so, we have an exciting opportunity for you: Financial Controller Central Eastern Europe Our...
-
Phd Candidate On a Stem Cell Therapy for Cornea
5 maanden geleden
Maastricht, Nederland Maastricht University Voltijd**Job description** The human cornea is a transparent tissue through which light enters the eye. Its innermost layer is composed of a tightly packed layer of corneal endothelial cells (hCEnCs). The density of our hCEnCs decreases with age, and diseases such as Fuchs’ endothelial corneal dystrophy or iatrogenic damage after surgery accelerate their loss,...
-
Senior Statistician.
6 maanden geleden
Maastricht, Nederland Medtronic VoltijdCareers that Change Lives The lifesaving work of medical professionals inspires us. Through partnerships with medical communities around the globe, we create advances in medical devices, supplies products to improve lives. From reducing surgery time to accelerating healing, our breakthrough solutions are a vital part of daily healthcare delivery. Through...