Huidige banen gerelateerd aan Regulatory Affairs Specialist - Den Haag, Zuid-Holland - Light Tree Ventures Group

  • Regulatory Affairs Expert

    4 dagen geleden

    Den Haag, Zuid-Holland, Nederland Light Tree Ventures Group Voltijd

    We are Light Tree Ventures, a dynamic company specialized in Research, Development and Manufacturing of LED Light Therapy products for Medical, Beauty and health.Our team of professionals is the heart of our company, encompassing a wide variety of cultures, therapy devices that are being sold online and offline. A fast and creative process, where innovative...

  • Regulatory Affairs Expert

    4 dagen geleden

    Den Haag, Zuid-Holland, Nederland Light Tree Ventures Group Voltijd

    **Company Overview:**Light Tree Ventures is a cutting-edge company that specializes in the development and manufacturing of LED Light Therapy products for Medical, Beauty, and Health industries.We have a strong presence globally, with offices in the Netherlands, China, the USA, and India, and our headquarters in The Hague.Our team of professionals is...

  • Medical Device Compliance Specialist

    4 dagen geleden

    Den Haag, Zuid-Holland, Nederland Light Tree Ventures Group Voltijd

    **About Us:**At Light Tree Ventures, we're dedicated to developing innovative LED Light Therapy products that improve people's lives.We believe in a collaborative work environment where talented individuals can thrive and contribute to our mission.**Your Role:**We're seeking an experienced International Regulatory Affairs Specialist to join our team in The...

  • International Compliance Specialist

    4 dagen geleden

    Den Haag, Zuid-Holland, Nederland Light Tree Ventures Group Voltijd

    Lights Tree Ventures Group is a company that specializes in research, development, and manufacturing of LED light therapy products for medical, beauty, and health purposes.We are looking for an experienced and ambitious International Regulatory Affairs (RA) Specialist to join our Dutch team.As RA Specialist, you will be responsible for conducting regulatory...

  • Consultant Public Affairs

    8 uur geleden

    Den Haag, Zuid-Holland, Nederland Nassau Group Voltijd

    About the Company Onze opdrachtgever is een eigentijds en ambitieus Public Affairs en Stakeholdermanagement bureau gevestigd in Den Haag. Zij zijn een specialist in Public Affairs, Stakeholdermanagement en Public Strategy. Zij adviseren hun opdrachtgevers over de te voeren strategie richting de politiek, overheid en maatschappij om hun doelstellingen te...

  • Consultant Public Affairs

    3 dagen geleden

    Den Haag, Zuid-Holland, Nederland Nassau Group Voltijd

    About the Company Onze opdrachtgever is een eigentijds en ambitieus Public Affairs en Stakeholdermanagement bureau gevestigd in Den Haag. Zij zijn een specialist in Public Affairs, Stakeholdermanagement en Public Strategy. Zij adviseren hun opdrachtgevers over de te voeren strategie richting de politiek, overheid en maatschappij om hun doelstellingen te...

  • Quality Assurance and Regulatory Specialist

    5 dagen geleden

    Den Haag, Zuid-Holland, Nederland Corsano Health Voltijd

    Corsano Health is at the forefront of developing, producing, and selling medically certified wearables for continuous vital sign monitoring. Our flagship product, the Corsano Solution, is a CE MDR certified and FDA Cleared system designed to monitor pulse rate, blood pressure, respiratory rate, SpO2, temperature, and activity.As a Quality Assurance and...

  • Quality Assurance and Compliance Specialist

    4 dagen geleden

    Den Haag, Zuid-Holland, Nederland QTC Recruitment Voltijd

    Job Summary:This Regulatory Affairs Expert position plays a critical role in maintaining and enhancing our Quality Management System as we transition to ISO 13485.The ideal candidate will have quality management knowledge and experience working in a MDR/ISO 13485 environment.Main Responsibilities:Lead the CAPA process and root cause analysis.Develop and...

  • Juridisch Adviseur Arbeidsrecht

    4 weken geleden

    Den Haag, Zuid-Holland, Nederland Odido Voltijd

    Ben jij een ambitieuze Legal Counsel met een passie voor juridisch vakmanschap? Kom werken bij Odido, waar je deel uitmaakt van een divers en gedreven team van juristen dat samen juridische grenzen opzoekt en waar nodig verlegt Als Legal Counsel ben je werkzaam in het Legal team binnen de afdeling Legal & Regulatory Affairs. Het Legal team bestaat op dit...

  • Stage consultant

    3 dagen geleden

    Den Haag, Zuid-Holland, Nederland Nassau Group Voltijd

    Onze opdrachtgever is een eigentijds en ambitieus Public Affairs en Stakeholdermanagement bureau gevestigd in Den Haag. Zij zijn een specialist in Public Affairs, Stakeholdermanagement en Public Strategy. Vanuit de samenwerking met een internationale netwerk organisatie op het gebied van Public Affairs beschikt onze opdrachtgever over een sterk...

  • Adviseur juridische en regulatory affairs

    8 uur geleden

    Den Haag, Zuid-Holland, Nederland Stichting Dranken Nederland Voltijd

    Onze wereld wordt steeds juridischer. Of het nu gaat over de naleving van allerlei (reclame) codes, wetsvoorstellen die onze sectoren raken, mededinging gerelateerde zaken, warenwet issues, (zelf) regulering op het gebied van circulariteit en duurzaamheid of vereniging gerelateerde zaken. Die zaken komen niet alleen uit 'Den Haag' maar ook steeds vaker uit...

  • Debt Management Specialist

    5 dagen geleden

    Den Haag, Zuid-Holland, Nederland Madison People International Voltijd

    **Job Description**We are looking for a highly skilled Debt Management Specialist to join our team at Madison People International. In this role, you will be responsible for managing intercompany borrowing and lending activities, ensuring compliance with regulatory requirements.Main Responsibilities:Managing end-to-end process of intercompany loans,...

  • Legal Counsel

    4 weken geleden

    Den Haag, Zuid-Holland, Nederland Odido Voltijd

    Ben jij een ambitieuze Legal Counsel met een passie voor juridisch vakmanschap? Kom werken bij Odido, waar je deel uitmaakt van een divers en gedreven team van juristen dat samen juridische grenzen opzoekt en waar nodig verlegt Dit ga je doen Als Legal Counsel ben je werkzaam in het Legal team binnen de afdeling Legal & Regulatory Affairs. Het Legal team...

  • Quality Control Technician

    2 weken geleden

    Den Haag, Zuid-Holland, Nederland Planet Pharma Voltijd

    Planet Pharma are seeking a highly motivated and detail-oriented Quality Control (QC) technician to join our client's team in a GMP-regulated laboratory . In this role, you will perform routine testing of samples, support method transfer, and assist in maintaining an efficient and compliant laboratory environment. You will also play a critical role in...

  • Strategisch Communicatie Specialist

    4 dagen geleden

    Den Haag, Zuid-Holland, Nederland Centraal Orgaan opvang asielzoekers (COA) Voltijd

    Als Corporate Communicatieadviseur bij COA word je de spil tussen bedrijfsdoelstellingen en communicatiedoelen. Jij maakt de connectie tussen operationele activiteiten en externe stakeholders. Je bent onze expert op het gebied van corporate communicatie en publieke diensten. Jij bent verantwoordelijk voor het gehele proces van communicatie-strategie tot...

  • Quality Onboarding Specialist

    3 dagen geleden

    Den Haag, Zuid-Holland, Nederland Qooling Voltijd € 55.000 - € 65.000

    We're seeking a Quality Onboarding Specialist to join our Implementation Team at Qooling. In this critical role, you will be responsible for ensuring new customers achieve quality standards when using our platform.As a Quality Onboarding Specialist, you will work closely with customers to identify areas of improvement and develop targeted strategies to...

  • Compliance and Governance Specialist

    2 dagen geleden

    Den Haag, Zuid-Holland, Nederland Altum Consulting Voltijd € 80.000 - € 90.000

    About the RoleWe are seeking a highly experienced risk and compliance professional to join our team at Altum Consulting.The successful candidate will be responsible for developing and implementing risk frameworks, managing due diligence for acquisitions, and ensuring compliance with evolving regulations such as AML, GDPR, DORA, and ISAE3402.Strong leadership...

  • Quality Assurance Specialist

    2 dagen geleden

    Den Haag, Zuid-Holland, Nederland BioTalent Voltijd

    Company Overview:BioTalent is partnered with a well-known global pharmaceutical business that has an excellent reputation in the industry.Job Description:We are looking for a permanent Quality Assurance (QA) specialist to join our quality division and support with all things compliance.Key Responsibilities:Ensure batch records, certificates of analysis and...

  • Quality Assurance Specialist

    4 weken geleden

    Den Haag, Zuid-Holland, Nederland QTC Recruitment Voltijd

    Overview: QTC are partnered with a leading Dutch medical device scale-up focused primarily in the opthalmic sector searching for a Quality Specialist to join their team based out of Den Haag. Due to increased demand, the organisation have ambitious growth plans over the coming year to increase from their current headcount of 30 FTE. Role: The Quality...

  • Credit Risk Management Specialist

    4 dagen geleden

    Den Haag, Zuid-Holland, Nederland Selby Jennings Voltijd

    Selby Jennings is excited to partner with a leading financial institution to find a skilled professional to lead the assessment and management of credit risk. This role is integral to ensuring regulatory compliance and developing robust risk management frameworks.Job Description:Credit Risk ManagementConduct thorough reviews of credit risk management...

Regulatory Affairs Specialist

1 maand geleden

Den Haag, Zuid-Holland, Nederland Light Tree Ventures Group Voltijd

Are you looking for a new opportunity and are you experienced in Regulatory Affairs?

This is a rare opportunity to be fully responsible to oversee all regulatory affairs for several different regions including (EU) MDR, FDA, TGA, UKCA and many more.

There are many different types of LED Light Therapy devices with different classifications, risk

profiles and regulatory pathways. It is a unique opportunity to get a wide overview of the Quality

and Regulatory space in Medical Devices and to work on many different projects with a global team.

About us

We are Light Tree Ventures, a company specialised in Research, Development and Manufacturing of

LED Light Therapy products for Medical, Beauty and health. We have offices in the Netherlands, China, the

USA, and India, with our headquarters in The Hague.

Our team of professionals are the heart of our company and encompass a wide variety of cultures,

skills, and competences. We love our work and share the ambition to be the best at what we

do: create meaningful, well-designed products for LED Light therapy markets worldwide.

Light Tree Ventures (LTV) works with brands from all over the world. We develop custom light

therapy devices that are being sold online and offline (in Sephora e.g.). This development is often a

R&D sprint, designing a prototype and getting it ready for production. A fast and creative process,

realizing the next generation product for a brand.

In our Dutch team we are looking for an experienced and ambitious International Regulatory Affairs (RA) Specialist.

So, what will you do exactly?

Job description

As RA Specialist you are involved in Regulatory affairs (regulatory product strategies and ensuring products get certified). This also includes staying in contact with external consulting companies advising LTV on regulatory affairs. As a QA/RA, you report on all Regulatory-related issues to top management. The RA has a direct link with the management team and reports on all other issues directly to the CEO.

For Regulatory affairs you will have the following responsibilities:

  • Answering regulatory related questions from/to leads and customers.
  • Responsible for being the regulatory affairs team member during projects. Researching regulatory requirements for designed and developed products.
  • Conducting and approving a regulatory analysis and conformity assessment to define the pathway towards regulatory clearance for LTV's (Medical) devices.
  • Researching and defining applicable International Safety Standards for products.
  • Responsible for the execution of Product Validation, including Safety Testing, usability studies, clinical evidence reports, comparison to predicate devices.
  • Creating, assembling, and reviewing documentation to obtain Marketing Authorization in the different applicable jurisdictions.
  • Being in touch with external advisors on regulatory affairs and communicating their findings throughout the organisation.
  • The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured before a device is released. (Product Release).
  • The technical documentation and the EU declaration of conformity are drawn up and kept up to date.
  • The post-market surveillance obligations.
  • Reporting to Regulatory Authorities aligned with applicable regulatory requirements and QMS procedures.

Your skillset should include:

  • You have affinity for technology and product development
  • Knowledge and interest in the beauty, sport/health, and medical industry
  • A completed higher professional education (HBO) with relevant work experience
  • ISO13485 Introduction, implementation and internal auditor course completed + official certificate.
  • You are entrepreneurial and a good negotiator with insight and analytical skills
  • Flexible and positive attitude, ambitious and willing to learn
  • You like to think with the customer and have a high problem-solving capacity
  • You work precise, you're social and stress resistant
  • You have good knowledge of MS Office
  • Excellent communication skills, written and verbal in English (Chinese (Mandarin) is a plus)
  • You are conscientious and well organised
  • Ability to work in an international team and independently
  • Willing to travel for work frequently

What we offer:

  • A highly motivated, young, hardworking and practical international team.
  • Enough opportunities to develop yourself.
  • Awesome products and international clients to work with.
  • Proper salary, holiday allowance, vacation days.
  • Company laptop and phone
  • Budget for personal development
  • Your work contributes to the health of the general public.
  • Opportunities to travel the world.
  • Plenty of coffee. Or Tea.
  • Cosy Friday afternoon drinks.

We are Light Tree Ventures and looking to expand our team and improve the world. Will you join us

in this amazing adventure? Get in touch by sending an email to adventure@lighttreeventures.com.

We would love to hear from you

With bright regards,

Light Tree Ventures