As a solution partner for digital pathology, we offer customized products ranging from small-scale digitization for field offices and frozen sections to fully digitized laboratories. Our focus is on accelerating the workflow in pathology, improving diagnoses, and digitally connecting physicians. For the establishment and further development of our quality management, we are looking for a Regulatory Affairs Manager (f/m/d).
- Expansion, further development as well as implementation and certification of a quality management system according to ISO 13485
- National and international projects
- Approval of products, including preparation of approval documents as well as internal and external coordination with regulatory authorities in the EU and the USA
- Preparation and maintenance of technical documentation, CAPA, and risk management
- Preparation, execution, and support of internal and external audits
- Determination and implementation of regulatory requirements as well as adaptation in case of changes in standards and legislation
- Control and preparation of data and key figures for management evaluation
- Cooperation in software validation within the quality management system
- Maintenance of the document control system
- Completed scientific or technical studies, preferably with additional qualification
- Professional experience in quality management according to ISO 13485 with knowledge of MDR and IVDR, as well as confident handling of standards and regulatory requirements and US regulations
- Ideally, experience in the preparation of technical documentation and/or registration dossiers
- Fluent German and excellent English skills
- Confident user skills in MS-Office
- Commitment, good time management, and strong communication skills
- Consultation skills combined with assertiveness
- High ability to work under pressure with quick comprehension
What you can look forward to
In the Smart In Media team, you will have the opportunity to help shape the future of digitizing medicine – in a creative atmosphere, international environment, and with a fair salary. Further benefits:
- Permanent position and full-time
- Initial training & support from the team
- Team supporting events
Are you interested?
Then we look forward to meeting you. Please send us your complete application documents with salary requirements. You are also welcome to include a short video in which you tell us about your experience and what appeals to you about this position and why this position is exactly right for you (max. 20 MB). Your contact person is Erika Mücke, e-mail: firstname.lastname@example.org
To all recruitment agencies: Smart In Media does not accept agency resumes. Please do not forward resumes to our jobs alias, Smart In Media employees, or any other organization location.
To protect the interests of all parties, Smart In Media will not accept unsolicited resumes from any source other than directly from a candidate. Any unsolicited resumes sent to Smart In Media will be considered Smart In Media property. Smart In Media will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Smart In Media will consider any candidate for whom an agency has submitted an unsolicited resume to have been referred by the agency free of any charges or fees.
Agency must obtain advance written approval from Smart In Media’s recruiting function to submit resumes, and then only in conjunction with a valid fully-executed contract for service and in response to a specific job opening. Smart In Media will not pay a fee to any agency that does not have such an agreement in place.