Manager (f/m/d) Regulatory Affairs Submission - (XO-935)

Manager (f/m/d) Regulatory Affairs Submission - (XO-935)

01 nov

01 nov



Are you ready to go further?

At HARTMANN you get to make a difference. Our healthcare products and solutions make an impact in millions of people’s lives around the world on a daily basis – in hospitals, in clinics, and at home. We believe that health can empower people to make a positive difference in the world, and this is something worth going further for.

Join our team as a

Manager (f/m/d) Regulatory Affairs Submission - Temporary for 2 Years -


As part of the Regulatory Affairs team, we offer you an exciting and responsible role in a globally operating area.

We enable our employees to get involved in interesting tasks in a modern working environment and to grow with them – personally and professionally. If you are as enthusiastic about our meaningful product portfolio as we are, we should get to know each other.

Your area of responsibility:

- In this role you act as a regulatory competent contact person for Business Divisions, Regions and international distribution partners with regard to global submission management of our product portfolio

- Together with your team you are responsible for the management of the required submission documentation with focus on countries outside European Union / EFTA 

- Coordination of submission activities with your global colleagues and distribution partners

- Accompany and monitor the submission process from request till received approval

- Working in a global RA Team and sharing your best practices 

What we look for:

- Bachelor degree in natural or technical sciences or equivalent

- Ideally first experience in the field of Regulatory Affairs in the health care industry

- Ideally knowledge or experience in submission processes for medical devices globally 

- Knowledge in basic regulatory requirements for medical devices, e.g. Regulation (EU) 2017/745, ISO13485

- Interest to work in an international team

- Fluent in English; good knowledge of German is advantageous


- Various health and fitness offers, e.g. yoga during lunch break, cooperation with fitness studios, company doctor, massage offers

- Furnished apartment for the first six months, if distance to place of residence > 60 km

- Well-developed infrastructure e.g. canteen, parking bays, well-equipped workspaces

- Attractive ways of combining work and family life, e.g. parent-child workroom

- Flexible working conditions, e.g. flexitime or mobile working on a daily basis

- Feedback conversations and resulting training opportunities

- Diverse development opportunities - national and international

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