Regulatory Affairs Manager
We are an internationally successful and established company with employees in Zurich and in Andover, USA. For more than 20 years, NDD Medizintechnik AG has created solutions that improve early detection of chronic lung diseases, including COPD and asthma. Today, NDD Medizintechnik AG offers unique spirometry and PFT device solutions that are available in more than 100 countries around the globe. We encourage innovation and teamwork, which enables us to continually develop our technology and products.
You will be part of a small, but strongly motivated and engaged team in an international environment, which is guarantying that the processes required by the standard are in place and applied in the company. With your skills and commitment, you will contribute to an Early Diagnosis for Better Lung Health for thousands of people. Join us and help us grow!
If you recognize yourself in the profile, and you would like to work in a small company where you can help develop excellence, then we should meet! We are looking forward to receiving your application including a motivation letter (English or German), your curriculum vitae and job references. Your data will be handled confidentially and discreetly.
Direct applications are preferred; we do not accept profiles coming from recruiting partners for this role.
...ideally consists of the following tasks
- Create, maintain, and update technical documentation to get/ keep marketing authorization established on an international scale.
- Manage pre-submissions and submissions to international authorities (compile required documentation) for NDD products, projects and interact directly with competent authorities or with NDD entities and NDD’ s in-country agents and contract distributors.
- Collect, analyze, and evaluate post-market surveillance data and create respective reports (PMS plan and report, PSUR). Ensure the information sharing between stakeholders.
- You will play an important role in reporting, managing and limiting regulatory incidents.
- Ensuring compliance with applicable regulations (e.g. MDR, MDSAP), and maintain processes for regulatory compliance.
- Contribute to the definition and the implementation of regulatory strategies to expand the business (geographic expansion, new indications...) and support/maintain registrations and support the organization with all sorts of regulatory information.
- Support and participate in development and change projects to ensure RA compliance and create necessary regulatory requirements and documents.
We are looking for a pro-active, open-minded, and engaged personality who has:
- A bachelor’s degree in Life sciences (Master is a plus), with 5+ years’ experience in Regulatory Affairs Management
- 3+ years’ experience within a global medical devices’ regulatory environment
- Expertise in the creation and maintenance of technical files for active electrical medical devices.
- Excellent knowledge of the process for developing and launching products in the EU, MDSAP and internationally.
- Excellent English- and German-Language skills; Conversational skills in Spanish and/or Portuguese are a strong plus.
- Analytical thinking and strong scientific documentation skills.
- Strong communication, solution-oriented, organizational, and tracking skills
- Knowledge in Biocompatibility, Hygiene, Clinical Evaluation, Risk Management, Validation and Verification activities is a strong plus.