Regulatory Affairs and Quality Assurance Vice President

il y a 4 semaines


Antwerp, Belgique Nipro Europe Group Temps plein
Regulatory Affairs and Quality Assurance Vice President - Mechelen - Nipro Europe Group

The Vice President of Regulatory Affairs, Clinical Affairs, and Quality Assurance will lead the RA/QA/CA team within Nipro Medical Europe, ensuring compliance with quality and regulatory requirements for medical devices.

This role is responsible for ensuring that NME and its manufacturing facilities meet obligations described in the Medical Devices Regulations, including regulatory compliance, vigilance, post-market surveillance, and clinical evaluation.

The successful candidate will also be responsible for product registrations according to applicable country/market requirements within the NME territory.

Key Responsibilities:

  • Develop and implement regulatory affairs processes to ensure compliance with current country regulations and requirements.
  • Ensure processes are developed to ensure compliance with environmental requirements for the distribution and import of medical devices.
  • Integrate regulatory and clinical planning with other functional leaders to plan for new or modified products or processes.
  • Coordinate with other functional leaders to review and agree registration timelines and resource requirements.
  • Ensure that regulatory and environmental non-compliance is communicated to NME Management Team.
  • Act as the PRRC to verify regulatory compliance of medical devices where NME is Authorized Representative.
  • Manage, guide, and coach the RA Team to create and/or maintain compliance to applicable regulatory requirements.
  • Accountable for incident reporting to Competent Authorities.
  • Ensure the team meets regulatory requirements related to timely reporting, accurate, and comprehensive medical device reporting and follow-up.
  • Manage, guide, and coach the Complaint and PMS Team.
  • Develop a clinical strategy, plan, and manage Nipro Medical Europe Clinical Studies in collaboration with NME Marketing Team and Global Product Development Team.
  • Ensure Clinical Evaluation processes are in accordance with applicable regulation and internal procedures.
  • Act as Management Representative for NME in accordance with ISO 13485:2016.
  • Ensure processes needed for Quality Management System are established, implemented, and maintained.

Requirements:

  • University degree in a scientific field or equivalent by experience.
  • Strong experience in RA and QA departments within the Medical Devices sector.
  • Experience with MDRs.
  • Excellent people management skills, able to lead managers.
  • Ability to create and lead a strategy.
  • International experience.

Estimated Salary: €120,000 - €150,000 per year

#J-18808-Ljbffr

  • Antwerp, Belgique TN Belgium Temps plein

    Social network you want to login/join with:Associate Director Regulatory Affairs, AntwerpClient:Regulatory affairsLocation:Antwerp, BelgiumJob Category:OtherEU work permit required:YesJob Reference:109d12980fa4Job Views:26Posted:23.01.2025Expiry Date:09.03.2025Job Description:QbD Austria, part of the international QbD group, is a young and growing consulting...


  • Antwerp, Belgique TN Belgium Temps plein

    Associate Director/Director Regulatory Affairs, AntwerpClient: Regulatory affairsLocation: Antwerp, BelgiumJob Category: OtherEU work permit required: YesJob Reference: 13bd1291501eJob Views: 26Posted: 23.01.2025Expiry Date: 09.03.2025Job Description:The UK team of the international QbD group is a specialist regulatory and pharmacovigilance consultancy...


  • Antwerp, Belgique TN Belgium Temps plein

    Regulatory Affairs Specialist – Medical Devices, AntwerpClient:Regulatory affairsLocation:Antwerp, BelgiumJob Category:OtherEU work permit required:YesJob Reference:e8c73abab4dbJob Views:61Posted:23.01.2025Expiry Date:09.03.2025Job Description:At QbD, our RA Services go from regulatory strategy, clinical, technical file to Vigilance. We support from idea...


  • Antwerp, Belgique PSA Belgium Temps plein

    You will play a pivotal role in advancing PSA’s policy objectives by managing relationships with European institutions, national governments, industry associations, and other key stakeholders. Role: You will be responsible for monitoring and shaping regulatory developments, identifying and securing public funding opportunities, and supporting business...

  • Quality Assurance Auditor

    il y a 4 semaines


    Antwerp, Belgique SGS Group Belgium Temps plein

    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 into depths of their discipline. We are equally as much looking for colleagues who we call ‘connectors', people who can connect our diversity to our services....

  • Quality Consultant

    il y a 2 semaines


    Antwerp, Belgique MindCapture Temps plein

    What Do We Offer? MindCapture creates a dynamic and stimulating work environment with a strong focus on the candidate. We believe in building sustainable relationships based on high-quality connections and insights into career opportunities—not just for our candidates but also for our consultants, recruiters, and support staff. We reward you with...


  • Antwerp, Belgique J&J Temps plein

    Regulatory Compliance AssociateLocation: Turnhoutseweg, BeerseDuration: End of 2025 initiallyHours: 40 hours per week, on-siteImagine your next project as a Regulatory Compliance Associate, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!roles and responsibilitiesYou will play a key...

  • Principal Medical Writer

    il y a 3 semaines


    Antwerp, Belgique Syneos Health, Inc. Temps plein

    Principal Medical Writer (Regulatory Submissions)Updated: January 31, 2025Location: Belgium-Europe - BEL-Home-BasedJob ID:25001444Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern...

  • QA/QC manager

    il y a 3 semaines


    Antwerp, Belgique The Specialist Group Temps plein

    ResponsibilitiesReview, approve, and maintain quality standards, procedures, and documentation.Lead the overall quality strategy for the Project Delivery Team.Develop and implement a comprehensive Quality Management System (QMS) to support all project phases.Closely monitor the EPCM contractor’s adherence to quality processes and standards.Conduct thorough...

  • Quality Assurance Coordinator

    il y a 4 semaines


    Antwerp, Belgique Q8 Temps plein

    Quality Assurance Coordinator page is loadedQuality Assurance CoordinatorApply locations Antwerp, Belgium time type Full time posted on Posted 11 Days Ago job requisition id R0002860Quality Assurance CoordinatorBen jij klaar om ons shopnetwerk naar hogere kwaliteitsstandaarden te tillen?Voortdurend verbeteren en in gesprek gaan met uitbaters geeft jou...


  • Antwerp, Belgique RSA Luxembourg (Europe) Temps plein

    At RSA Luxembourg (RSAL) our purpose is to help people, businesses, and society prosper in good times and be resilient in bad times. With our head office in Luxembourg, and branches in Belgium, France, Spain, the Netherlands and the UK, we’ve embraced hybrid working and empower our 250 plus people to work flexibly in their country of employment, to suit...


  • Antwerp, Belgique TN Belgium Temps plein

    Social network you want to login/join with:Computerized System Assurance Expert - Kontich - Crosspoint Solutions, KontichClient:Crosspoint SolutionsLocation:KontichJob Category:OtherEU work permit required:YesJob Reference:a5f12eb88debJob Views:5Posted:15.02.2025Expiry Date:01.04.2025Job Description:Are you a consultant at heart? Are you ready to help shape...


  • Antwerp, Belgique TN Belgium Temps plein

    Social network you want to login/join with:Computerized System Assurance Expert - Kontich - Crosspoint Solutions, DuffelClient:Crosspoint SolutionsLocation:Duffel, BelgiumJob Category:OtherEU work permit required:YesJob Reference:2e215c5e2f5fJob Views:5Posted:15.02.2025Expiry Date:01.04.2025Job Description:Are you a consultant at heart? Are you ready to help...

  • Quality Assurance Manager

    il y a 3 semaines


    Antwerp, Belgique Motmans & Partners bvba Temps plein

    Solliciteer je voor een job in de publieke sector? Zorg dan dat je alle nodige documenten meelevert met je sollicitatie.OrganisatieMotmans & Partners, met kantoren in onder meer Antwerpen, Diegem, Hasselt en Eindhoven is een sterke dienstverlener op het vlak van Human Resources. Onder het motto ‘Leading Ambition’ bieden onze ervaren consultants maatwerk...

  • Medical Device Specialist

    il y a 3 semaines


    Antwerp, Belgique TN Belgium Temps plein

    Social network you want to login/join with:Clinical, Qualification & Validation, Quality management, Regulatory affairs, Software validationAre you an expert within medical devices and passionate about helping companies in this area in their growth or to achieve their ISO13485 certificate? Apply now for the job of Medical Devices Specialist at QbD!Table of...

  • VP Operations

    il y a 3 semaines


    Antwerp, Belgique Loop Earplugs Temps plein

    We are LoopLoop Earplugs is reinventing how people experience the world by enabling them to live life at their own volume. 2024 was a pivotal year at Loop – we hit 14,000,000 earplugs sold, were named ‘The Best Earplugs for Concerts’ by The New York Times, and expanded our product offering to a complete range of solutions for day and night. Oh – and...

  • Quality Manager

    il y a 4 semaines


    Antwerp, Belgique Nutripack Temps plein

    As a specialist in food packaging, we manufacture and distribute packaging solutions for the agri-food and food services industries. Our business involves taking responsibility for our practices and rethinking our materials.That's why we're committed to being a designer and developer of solutions for food containers, committed to effectively reducing our...

  • Quality Assurance Engineer

    il y a 4 semaines


    Antwerp, Belgique Square City Temps plein

    Verwacht het onverwachte voor jouw talent!Square City werkt als trusted advisor voor profielen in office, logistiek, supply chain & engineering. Wij bieden expertise, dialoog en continuïteit om als selectiepartner de juiste match te vinden voor onze klanten en kandidaten. Door ons uitgebreid netwerk van professionals en de persoonlijke benadering van onze...

  • Associate Medical Director

    il y a 4 semaines


    Antwerp, Belgique Galapagos Temps plein

    Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules,...

  • M&A VP/Director

    il y a 1 semaine


    Antwerp Metropolitan Area, Belgique Selby Jennings Temps plein

    M&A VP/Director – Antwerp - Dutch SpeakingLocation: Antwerp, BelgiumExperience: 7+ Years in M&AAre you an experienced M&A professional with a proven ability to originate and execute deals? Our client, a leading financial advisory firm, is seeking a Vice President or Director to join their growing dynamic M&A team in Antwerp. This is a unique opportunity to...