Regulatory Affairs Manager

Reference number:
**req9078**
- Location:
**Germany nationwide or Austria (100% Mobile Work)**
- Job segment:

- **Software Development**
- Contact:
- Leading international e-health company
- 837 million € annual sales in 2020
- Approx 8.500 employees worldwide
- Unique customer base with over 1.6 million professional users worldwide
- Locations in 18 and products in 56 countries
- Over 30 years of success

Become ALL IN as a Regulatory Affairs Manager (M/F/d)

CompuGroup Medical is one of the world's leading eHealth companies. Its software products to support all medical and organizational activities in doctors' practices, pharmacies, laboratories and hospitals, its information services for all stakeholders in healthcare and its web-based personal health records serve a safer and more efficient healthcare system.

As Regulatory Affairs Manager (M/F/d) you are responsible for the proper and economic implementation of relevant rules and processes for compliance with legal and normative requirements for software product development within a business area of CGM. This includes, in excerpts, the Medical Device Regulation (2017/745 (EU)) and local medical device laws, relevant standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, etc.) and internal company guidelines and requirements.

Your Contribution:

- Researching and implementing international standards in internal processes or advising the specialist department on their implementation
- Regulatory support of development teams to improve internal processes
- Preparation of documents for certification of software medical devices according to Medical Device Regulation (MDR) and
- Quality Management System for Medical Devices (ISO 13485)
- Performing risk assessments for software medical devices as well as planning and conducting internal audits, briefings and trainings
- Contribute to continuous improvement initiatives and activities within the Quality organization

Your Qualification:

- Completed scientific or technical studies, alternatively comparable qualification
- At least 3 years of experience in the QM environment and in the medical devices software environment
- Knowledge of compliance requirements for medical devices
- Knowledge of laws and knowledge of (in extracts) Medical Device Regulation, local medical device laws and regulations (MPSV, MPBetreibV), GDPR,...
- A high level of communication and teamwork skills
- Business fluent German and English skills

What you can expect from us:

- A crisis-proof permanent position
- A wide range of development opportunities and long-term perspectives within our growing company
- Digital Feel Good Management with a variety of offers for your health,
z. e.g. home workouts, nutritional counseling, mental training, etc.
- Modern workplaces, flexible working hours, mobile working,
employee discounts, and much more ensure a pleasant working environment

Synchronizing Healthcare

Become ALL IN with head, heart, and hand