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