Regulatory Affairs Officer - Regulatory Product Owner

Regulatory Affairs Officer - Regulatory Product Owner

As the Regulatory Affairs Officer - Regulatory Product Owner you will ensure that the contents of DORCs global technical files contain evidence of compliance with applicable international product and process standards at all times.

Main responsibilities:

The activities listed below relate to the assigned product portfolio:

• Maintain a thorough and up-to-date knowledge of applicable product and process standards and communicate upcoming changes to relevant stakeholders in a timely manner
• Ensure that the content of the Global Technical Dossier is in compliance with product and process related standards recognised by the major regulatory systems (CE and FDA)
• Core team member regulation of DTP projects and go-to person for ECFs
• Develop regulatory strategies for newly developed products, including the list of applicable standards to be demonstrated for compliance;
• Document and coordinate regulatory impact assessments of product or process changes and ensure that technical documentation is prepared to support approval of the change in the markets where the product is approved
• Obtain regulatory approval in the first market(s) for newly developed products;
• Participate in strategic business projects. Act as an internal regulatory consultant to the NPD and Sustaining organisation at all stages of projects. Provide pragmatic, yet compliant and ethical solutions to regulatory challenges
• Support Regulatory Officers in answering technical questions from regulators
• Support the Regulatory Operations organisation in answering RA Helpdesk questions.

Skills, knowledge and experience:

• Minimum of 5 years in the medical device industry in a regulatory position
• Thorough knowledge of technical product and process standards and key regulatory frameworks
• Preferably you have an electrical background
• Ability to effectively translate and communicate regulatory requirements into technical language
• Ability to critically and constructively review technical documentation for compliance with standards
• Ability to multi-task and methodically manage projects based on business professionals and resource availability
• Able to self-motivate and work independently in a geographically separated multi-national and multi-functional team environment
• Works effectively together in a diverse network of strong personalities
• Open to opportunities for improvement and change towards best-in-class compliance performance
• Able to think creatively, proactively identify alternative solutions to problems
• Excellent communication/interpersonal skills
• Fluent in Dutch and English (written and spoken)
• Advanced level in Microsoft Office
• Technical / professional qualifications
• Minimum of a bachelors degree in a relevant technical direction.

Does DORC make you happy?

Does working for you mean working together? Realising surgical devices together that help to make people see again? With a hands-on and both legs on the ground mentality? Do you want to work for an organisation where you get freedom and responsibility? Where you are fully stimulated to come up with new ideas? And where innovation, quality and technology are woven into the DNA? Then DORC is the place for you.

Would you like to know more about working at DORC? Then read on here.

What does DORC have to offer you?

At DORC, you play at top level. It is therefore only logical that we reward you as a top player. You can expect the following:

• 27 holidays and 13 adv-days for a 40-hour full-time job
• 8% holiday pay
• 13th month
• Bonus scheme
• A travel allowance of € 0.23/km
• And a non-contributory pension, which means you will receive a substantially higher net salary

What else can you expect from us? Every opportunity to learn and grow. Your own laptop and smartphone. And a fantastic company restaurant full of delicious, fresh products.

Will you be our new Regulatory Affairs Officer - Product Owner?

The Netherlands

QA & RA