Director Regulatory Affairs and Quality

vor 2 Wochen

Hamburg, Deutschland ApoQlar Vollzeit

**Make a positive impact in the global healthcare community with **c**utting-edge** **medical mixed reality technology.**

apoQlar is the developer of a medical mixed reality platform that is revolutionizing how medicine is practiced, experienced, learned, and shared. Our flagship product, VSI HoloMedicine®, is a medically certified software platform that leverages the Microsoft HoloLens hardware to transform medical images, clinical workflows, and medical education into an interactive 3D mixed reality environment.

With offices in Miami, Poznan, Singapore and our headquarters in Hamburg we are dedicated to revolutionizing the healthcare industry by leveraging cutting-edge technology and innovative solutions.

We are currently looking for an enthusiastic and motivated individual to join our team in Hamburg (onsite/hybrid) to expand our rapidly growing Regulatory & Quality Management team. You will take a leading role within the Regulatory & Quality Management team and work closely with C-Level as well as our engineering teams to ensure our mixed reality platform is in compliance with regulatory and statutory requirements.

**Responsibilities** include**:

- Lead the regulatory approval processes globally.
- Lead the development of regulatory responses for questions from notified bodies, global regulators and regulatory representatives upon review of submissions in relation to the technical dossier.
- Implement regulatory requirements in accordance with EU MDR 2017/745.
- Lead risk management activities and work closely with the risk management team through the life cycle of medical device software.
- Participate in and support external/internal audits and responses to audit findings as appropriate.
- Ensure compliance with the current regulatory procedures and update the procedures when new regulatory requirements are determined.
- Monitor the new/revised applicable regulatory requirements, standards, guidance, and common specifications.
- Handle serious incident and adverse event reporting.
- Ensure that the communication with Notified Bodies and Regulatory Authorities is effective and that all the required information is provided.
- Ensure that marketing communication is according to regulatory requirements.
- Ensure that regulatory and statutory requirements are fully met across the whole organization.
- Ensure the promotion of awareness of applicable regulatory requirements throughout the organization.
- Act as appointed Person Responsible for Regulatory Compliance (PRRC).

**Qualifications**:

- University degree in biomedical science, engineering, pharmacy, or any other applied natural sciences.
- 7+ years of professional experience including MDD/MDR and FDA submissions.
- Proficient knowledge of EU medical device regulations and Quality Management Systems for medical devices.
- Knowledge of MDSAP, ISO 13485, IEC 62304 and ISO 14971.
- Experience in communication with authorities and notified bodies.
- Excellent writing skills.
- Experience in communication with healthcare professionals.
- Excellent planning and project management skills.
- Critical thinking.
- Experience in external and internal Audits.
- Fluency in English is a requirement, German is a huge plus.

**Why Us?**
- Chance to work with new and exciting technologies.
- Opportunity to positively impact the lives of patients, students, and surgeons around the world.
- Chance to not just shape but also create an entirely new market in healthcare using medical mixed reality.
- Work alongside a multicultural and international team - over 10 countries represented in our office.
- A flat hierarchy with direct access to the founding team and C-Level.
- High degree of ownership with the opportunity to drive projects forward on your own or with a team.
- Competitive compensation structure and ability to grow quickly within an advancing team.

Are you interested in helping us shape an entirely new market in healthcare and advancing next generation medical technology? Then we look forward to hearing from you

  • Director Quality and Regulatory Affairs

    vor 2 Wochen

    Hamburg, Deutschland EVIDENT Europe GmbH Vollzeit

    As the Director Quality and Regulatory Affairs (M/F/d) you support business units and functions in creation, implementation and maintenance of processes and related documented information. Tasks As the Director Quality and Regulatory Affairs (m/w/d) you support business units and functions in creation, implementation and maintenance of processes and...

  • Associate Regulatory Affairs

    vor 1 Woche

    Hamburg, Deutschland two.jobs Vollzeit

    For our customer Selectchemie AG we are looking for a Associate Regulatory Affairs / Quality Assurance (100%) About Selectchemie AG Selectchemie is an independent Swiss company serving the pharmaceutical and nutrition industry since 1969 as a premier supplier of high quality ingredients and generic finished dosage forms. As a full-service provider we...

  • Werkstudent Quality and Regulatory Affairs

    vor 2 Monaten

    Hamburg, Deutschland D.Med Consulting GmbH Vollzeit

    Die D.Med Consulting GmbH ist ein Zusammenschluss der Fresenius Medical Care AG & Co. KGaA (51%) und der D.Med Healthcare Gruppe (49%), einem weltweit operierenden Anbieter von medizinischen Dienstleistungen und Medizinprodukten im Bereich Nephrologie, Kardiologie und der Inneren Medizin. Gegründet 2011 und mit Hauptsitz in Hamburg steht die D.Med...

  • Working Student

    vor 2 Wochen

    Hamburg, Deutschland D.Med Consulting GmbH Vollzeit

    D.Med Consulting GmbH is a joint venture between Fresenius Medical Care AG & Co. KGaA (51%) and the D.Med Healthcare Group (49%), one of the world’s leading operators of medical devices and medical products in the field of Nephrology, Cardiology and Internal Medicine. Founded in 2011 and seated in Hamburg, D.Med Consulting GmbH provides first-class...

  • Quality and Regulatory Affairs Manager

    vor 1 Monat

    Hamburg, Deutschland GAIA AG Vollzeit

    Die GAIA AG zählt zu den weltweit führenden Unternehmen im Bereich Digital Health. Mit Therapiesoftware wie deprexis® setzen wir den Standard für Evidenz und Innovation. Bei uns sind therapeutische, wissenschaftliche und technologische Kompetenz unter einem Dach vereint. Wir entwickeln nicht nur digitale Therapieunterstützungsprogramme, sondern sind...

  • Regulatory Affairs Associate

    vor 3 Wochen

    Hamburg, Deutschland Essity Vollzeit

    **Regulatory Affairs Associate **(d/f/m)**: Essity is a leading global hygiene and healthcare company. We are committed to improving the quality of life through high-quality hygiene and healthcare solutions. We sell our products and solutions in around 150 countries under many strong brands, including the global market leaders TENA and Tork, as well as...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Hamburg, Deutschland Olympus Europa SE & Co. KG (OEKG) Vollzeit

    **Responsibilities**: - Contact point for regulatory requirements for the market access in the EU, EFTA and Europe - Registration support in EU, EFTA and Europe - Regulatory consultant in the launch of new products - Regulatory assessment for Product launches - Ensuring regulatory compliance in EU - Execute regulatory related projects in EMEA Your...

  • Regulatory Affairs Specialist

    vor 2 Monaten

    Hamburg, Deutschland Barrington James Vollzeit

    Hamburg, Germany - 22-05-2023 - JOB TYPE - Permanent - EMP TYPE - Full-Time - EXPERTISE - QA / RA - SALARY TYPE - Annually - SALARY - Negotiable My client are a renowned medical technology company with over 30 years of experience in developing and manufacturing innovative solutions. Based in Hamburg, the family-run organization has earned a prominent...

  • Working Student

    vor 2 Wochen

    Hamburg, Deutschland EVIDENT Europe GmbH Vollzeit

    Aufgaben - Coordination of regulatory activities to collect registration information from distributors - Creating and issuing of Confirmation of conformance on customers demand - Creating and providing of documents for local registration within EMEA region - Support Head of Quality and Regulatory Affairs - Development and writing of SOP for RA topics -...

  • Regulatory Affairs and Qms Lead

    vor 4 Wochen

    Hamburg, Deutschland ApoQlar Vollzeit

    Make a positive impact in the global healthcare community with cutting-edge medical mixed reality technology._ apoQlar is the developer of a medical mixed reality platform that is revolutionizing how medicine is practiced, experienced, learned, and shared. Our flagship product, VSI HoloMedicine®, is a medically certified software platform that leverages...

  • Regulatory Affairs and Qms Lead

    vor 28 Minuten

    Hamburg, Deutschland ApoQlar Vollzeit

    Make a positive impact in the global healthcare community with cutting-edge medical mixed reality technology._ apoQlar is the developer of a medical mixed reality platform that is revolutionizing how medicine is practiced, experienced, learned, and shared. Our flagship product, VSI HoloMedicine®, is a medically certified software platform that leverages...

  • Assistant Regulatory Affairs

    vor 2 Monaten

    Hamburg, Deutschland altona Diagnostics GmbH Vollzeit

    To strengthen our Regulatory Affairs team in Hamburg, we are looking for a highly motivated and dedicated **Assistant Regulatory Affairs (M/F/d)** **Your responsibilities***: - Administrative support of our Regulatory Affairs team - Participation in the creation and maintenance of the Technical Documentation - Communication of product changes to...

  • Regulatory Affairs Associate

    vor 3 Wochen

    Hamburg, Deutschland Essity Vollzeit

    Regulatory Affairs Associate  (d/f/m) Essity is a leading global hygiene and healthcare company. We are committed to improving the quality of life through high-quality hygiene and healthcare solutions. We sell our products and solutions in around 150 countries under many strong brands, including the global market leaders TENA and Tork, as well as...

  • Regulatory Affairs Associate

    vor 2 Wochen

    Hamburg, Deutschland Essity Vollzeit

    Regulatory Affairs Associate  (d/f/m) Essity is a leading global hygiene and healthcare company. We are committed to improving the quality of life through high-quality hygiene and healthcare solutions. We sell our products and solutions in around 150 countries under many strong brands, including the global market leaders TENA and Tork, as well as...

  • Regulatory Affairs and QMS Lead

    vor 2 Wochen

    Hamburg, Deutschland apoqlar Vollzeit

    Make a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.  About Us: apoQlar is the developer of a medical mixed reality platform that is revolutionizing how medicine is practiced, experienced, learned, and shared. Our flagship product, VSI HoloMedicine®, is a medically certified software platform that...

  • Regulatory Affairs and QMS Lead

    vor 4 Wochen

    Hamburg, Deutschland apoqlar Vollzeit

    Make a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.  About Us: apoQlar is the developer of a medical mixed reality platform that is revolutionizing how medicine is practiced, experienced, learned, and shared. Our flagship product, VSI HoloMedicine®, is a medically certified software platform that...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Hamburg, Deutschland GULP – experts united Vollzeit

    Are you a chemist or biologist looking for a new challenge in the pharmaceutical industry ? Are you passionate and committed to your profession and always give 100%? So do we! The satisfaction of our clients and candidates is our top priority when placing qualified specialists. We are currently looking for a Regulatory Affairs Specialist in Hamburg ...

  • Regulatory Affairs Manager

    vor 3 Wochen

    Hamburg, Deutschland GULP – experts united Vollzeit

    Are you a chemist or biologist looking for a new challenge in the pharmaceutical industry ? Are you passionate and committed to your profession and always give 100%? So do we! The satisfaction of our clients and candidates is our top priority when placing qualified specialists. We are currently looking for a Regulatory Affairs Specialist in Hamburg ...

  • Head of Regulatory Affairs and Qms

    vor 4 Wochen

    Hamburg, Deutschland apoqlar Vollzeit

    Make a positive impact in the global healthcare community with cutting-edge medical mixed reality technology._ **About Us**: apoQlar is the developer of a medical mixed reality platform that is revolutionizing how medicine is practiced, experienced, learned, and shared. Our flagship product, VSI HoloMedicine®, is a medically certified software platform...

  • Head of Regulatory Affairs and Qms

    vor 37 Minuten

    Hamburg, Deutschland apoqlar Vollzeit

    Make a positive impact in the global healthcare community with cutting-edge medical mixed reality technology._ **About Us**: apoQlar is the developer of a medical mixed reality platform that is revolutionizing how medicine is practiced, experienced, learned, and shared. Our flagship product, VSI HoloMedicine®, is a medically certified software platform...