You will only grow if you step out of your comfort zone
Over de functie
Yacht Life Sciences has a vacancy for a Senior Regulatory Affairs (RA) Specialist. This concerns a permanent position at our client, an international company in optic retailing.
This vacancy is part of the Global Quality Assurance and Regulatory Affairs Department. Their vision is to continuously enhance business capabilities by using quality management and regulatory compliance as a tool for competitive advantage. It is their mission to develop global processes aimed to achieving streamlined and compliant business operations, both internally and in the interaction with suppliers.
As a senior RA specialist, you will be responsible for the creation and maintenance of the Technical File and associated processes. Also, you will provide leadership and hands-on contribution for the post-market surveillance, risk management and vigilance processes. In addition, as a senior RA specialist, you will support the rest of the QA/RA team where and when required.
As a Senior RA Specialist, you will be measured on your ability to establish compliant Technical Files and associated processes. This role mostly includes dealing with Class I devices; however, the company portfolio also includes Class IIa and IIb devices. Furthermore, this role is based in the Global Corporate Headquarters, located in Schiphol Airport. However, international travel will be required.
Required qualifications/level of education
- The ideal candidate should have a Bachelor’s degree in a related discipline (e.g. engineering, law, philosophy).
- Strong but fair and data-driven personality.
- Ability to analyze regulations and suggest streamlined solutions to achieve compliance.
- Detailed knowledge of the regulatory environment for Class I Medical Devices.
- Strong planning, problem analysis and resolution, and organizational skills.
- Detect deviations from intended workflows and processes, with exceptional attention to details.
- Learn quickly and effectively, approaching new challenges by taking initiative.
- Scope, manage and prioritize multiple small projects simultaneously.
- Effectively present information to others, including senior management and its subsidiaries.
- Communicate clearly with all areas of the business and maintain inter and intra departmental relationships.
- Team-oriented with strong leadership and interpersonal skills.
- Able to effectively adapt to change (environment, requirements, roles, objectives).
- Demonstrated leadership and change management ability.
The ideal candidate shall:
- Be able to interpret regulations.
- Have previous experience in a similar role in the medical device or pharmaceutical industry.
- Be comfortable analyzing clinical risks associated with the use of the clients's devices.
- Be able to manage complex projects.
- Be willing to take on board new challenges with enthusiasm and professionality.
- Be fully proficient in English, particularly written, and Microsoft Office.
This concerns a full-time and permanent position directly at our client.
Our client is an international company in optical retailing and delivers high quality and affordable eye care to more and more customers around the world. The high quality eye care offered by our client includes a wide range of services provided by its vision experts, prescription glasses including frames and lenses, contact lenses and contact lens care products, and sunglasses both plain and with prescription lenses. These products are offered through leading optical retail banners.
Voor meer informatie neem je contact op met Gyöngyvér Lukács via telefoonnummer 06-10317714
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.