Ophthalmic Medical Device Auditor and/or Technical File reviewer

The business line Medical is a leading and fast-growing Notified Body for the medical device industry. As a result, we are consistently looking for medical auditors and/or technical file reviewers. Dealing with cutting-edge medical innovations, we provide our clients with worldwide market access through conducting conformity assessments for high-risk devices. We work together with a global team of approximately 150 experts, with the ultimate goal to ensure patient safety.

I.e. we are looking for specialists that have proper knowledge on intraocular lenses (implantable medical devices) and glaucoma implantable medical devices. You should preferably have good knowledge on the challenging developments in this area, being aware of the global players in the market in this clinical area. Next to proper knowledge on the devices itself, there is a pre when you may have knowledge on clinical usage of these devices, having gained knowledge and experiences in production of these ophthalmological implantable medical devices.

Responsibilities

After an extensive internal training program at our office in Arnhem, you will:

• Independently execute audits and related processes;

• Be responsible for the assessment of technical files and the auditing of quality systems for you customers, ranging from highly innovative start-ups to large multinationals, both nationally and internationally;

• Act as a key point of contact and maintain frequent contact with customers, colleagues, external experts such as physicians, contractors and authorities;

• Have the opportunity to represent DEKRA at conferences;

• As auditor you travel approximately 20-30% of the time, both within and outside Europe;

• Becoming proper knowledgeable counter partner in the ophthalmic field to your customers and to your internal DEKRA colleagues;

• As technical file reviewer it is possible to work 28 – 40 hours a week.

• A bachelor or university level degree in life and/or engineering sciences is a must;

• A minimum of 4 years of full-time work experience in the medical device industry, including at least 2 years in research & development or quality assurance/regulatory affairs;

• Experience in the following device category and area of expertise: ophthalmic;

• Experienced with quality management systems (ISO 13485) and relevant laws and regulations, at least CE (MDD/MDR);

• Project management and auditing experience is considered an advantage;

• English language skills are a must;

• You are preferably already live in the Netherlands or are willing to relocate to the Netherlands.

• Competitive salary and comprehensive benefits;

• A variable performance bonus scheme;

• 25 vacation days and 13 ADV (Additional Days Off) for ample relaxation;

• Travel and remote work allowances;

• Discount on various insurance plans;

• Abundant opportunities for career growth, supported by multiple training programs;

• Engage in a challenging role within a cohesive team of proficient experts in a dynamic and international setting.

More about DEKRA

DEKRA is the world's largest non-listed expert organization in testing, inspecting, and certifying according to international safety and sustainability standards. Founded in Germany in 1925, the company's mission was to inspect vehicles to ensure traffic safety. Today, we offer a wide range of services, from product safety testing, audits, and inspections to damage assessment and HSE consulting. We operate in over 60 countries to ensure safety on the road, at home, and in the workplace worldwide. Explore all our services here.

We have a clear mission: as a leader in testing, certification and inspection, we ensure that products, assets, and technologies are safe, reliable, and sustainable – building trust between people and technology. And you are welcome to join! Discover more about DEKRA here.

Questions?

Do you have any questions about this vacancy? Please contact Jaimie Houtters. You can reach her at +31 6 29 65 86 96 or by email to recruitment.nl@dekra.com.

DEKRA likes to look for new colleagues itself, acquisition in response to this vacancy is therefore not desirable.