Regulatory Affairs Specialist (80-100%)
ndd Medizintechnik AG is a leading company and innovator in pulmonary function testing devices. For morethan 25 years, ndd has created solutions that improve early detection of chronic lung diseases, including COPDand asthma. Today, ndd offers unique spirometry and pulmonary function testing devices that are availablearound the globe.
To strengthen our Quality Services team located in Zurich, Switzerland, we are looking for a hands-on andsolution-focused Regulatory Affairs Specialist (80-100%).
In this role, you will be part of a competent and dedicated team that performs in an international environment. Your key role is to support the cross-functional teams in establishing and complying with regulatory requirements, and to maintain the compliance of our medical devices. You manage the marketing from a regulatory perspective and support the regulatory approval process. Help us to make lung function testing accessible to everyone everywhere and to improve the lives of millions of people with lung diseases.
We offer an attractive location, fair pay, good social benefits, flexible working hours, hybrid work, and the best conditions in which to do excellent work. This includes comprehensive onboarding, professional and modern technology, and a collegial and supportive working environment. We promote equal opportunities, diversity, and inclusion – come as you are!
If this profile describes you and you would like to work at a fast-growing company in an international environment, then we should meet. Apply directly and exclusively via our e-recruiting tool. The more we learn about you, the better. We look forward to receiving your complete application and reference letters. Your data will be treated confidentially and discreetly.
- Defining regulatory requirements in support of new product introductions and lifecycle management projects.
- Creating and maintaining technical documentation (EU MDR) and US FDA submissions (e.g., 510(k)).
- Assessing impact of changes on product registration processes world-wide.
- Contributing to establishing product registration processes.
- Maintaining technical files for assigned products.
- Translating regulatory requirements for medical device labeling into applicable product requirements.
- Supporting creation and review of needed deliverables in accordance with the medical device development and change management processes.
- Maintaining and supporting international product registrations.
- Supporting the team with relevant regulatory deliverables in support of vigilance activities and during continuous improvement projects.
- Technical background, at least a basic degree in science (e.g., Biotechnology) or equivalent, advanced degree in science (Biotechnology) or equivalent is welcome.
- 1-3 years of experience in RA and/or QA in a medical device environment.
- Experience in working with ISO 13485, MDD, MDR and FDA 21 CFR.
- Fluency in both English and German; any other languages are a plus.
- You work in an independent manner and are a solution-focused, well structured, and collaborative person.
- Strong interpersonal skills and the ability to coordinate and work with cross-departmental teams.