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 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 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**:

- Develop and lead the regulatory strategy to ensure compliance with applicable laws, regulations and ensure a fast and efficient certification of new product developments.
- Maintain and optimize the current QMS and RA framework, focusing on specific processes such as change control, design controls, verification and validation, and risk management.
- 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.
- In-depth knowledge of Software Lifecycle Processes, including expertise in implementing the requirements of the IEC 62304 standard and AAMI TIR45 guidance (agile).
- Extensive experience in Software as a Medical Device (SaMD), covering design controls, risk management, verification and validation, SOUP (Software of Unknown Provenance), and Software Configuration Management (SCM).
- Demonstrated ability to maintain and streamline QMS for seamless use across the organization, ensuring a sustainable and compliant system.
- Experience in communication with healthcare professionals.
- Strong analytical skills to evaluate product compliance and interpret regulatory guidelines.
- Ability to collaborate effectively with internal specialists and other external consultants (if required), ensuring alignment and cooperation.
- 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 loo

  • 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 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 3 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...

  • 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...

  • 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...

  • Head of Regulatory Affairs and Qms Emea

    vor 1 Monat

    Hamburg, Deutschland apoqlar Vollzeit

    **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 leverages the Microsoft HoloLens hardware to transform medical images, clinical workflows, and medical...

  • Head of Regulatory Affairs and Qms Emea

    vor 2 Wochen

    Hamburg, Deutschland apoqlar Vollzeit

    **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 leverages the Microsoft HoloLens hardware to transform medical images, clinical workflows, and medical...

  • Werkstudent (M/w/d) Regulatory Affairs

    vor 2 Monaten

    Hamburg, Deutschland Promecon GmbH Vollzeit

    **Werkstudent/in Regulatory Affairs (m/w/d)** **Ort: Hamburg** **ab sofort** **Wir sind** Das in Hamburg ansässige Familienunternehmen PROMECON ist seit mehr als 20 Jahren international erfolgreich in der Entwicklung, Herstellung und dem Vertrieb von Medizinprodukten zum Einmalgebrauch. Zur Verstärkung unseres Teams suchen wir ab sofort einen...

  • Public Advocacy

    vor 2 Monaten

    Hamburg, Deutschland Corre Energy Vollzeit

    Corre Energy is a leader in the development and operation of Long Duration Energy Storage (LDES) projects and products that accelerate the transition to net zero and enhance security and flexibility of energy systems. Our initial market focus is Europe, with anticipated expansion into other major markets. LDES projects and products unlock the value of...

  • Public Advocacy

    vor 2 Monaten

    Hamburg, Deutschland Corre Energy Limited Vollzeit

    **Location: Germany** **Contract Type: Contract** **Duration 1 day per week in 2023, 2.5 days in 2024 then 5 days per week thereafter** **Location Remote** **Role Description** Manage external public relations and CAES (Compressed Air Energy Storage) advocacy in Germany to gain full support of CAES projects by German regulators, policy makers and public...

  • 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...

  • Regulatory Affairs Manager

    vor 3 Wochen

    Hamburg, Deutschland Olympus Vollzeit

    Ihre Aufgaben - Develop Regulatory Strategies: Lead the development and implementation of regulatory strategies for product registrations (primary focus Asia Pacific and China) Collaborate with cross-functional teams to ensure alignment with business objectives and regulatory requirements - Manage Registrations: Oversee the planning, preparation,...

  • Regulatory Affairs Manager

    vor 2 Wochen

    Hamburg, Deutschland Olympus Vollzeit

    Ihre Aufgaben - Develop Regulatory Strategies: Lead the development and implementation of regulatory strategies for product registrations (primary focus Asia Pacific and China) Collaborate with cross-functional teams to ensure alignment with business objectives and regulatory requirements - Manage Registrations: Oversee the planning, preparation,...

  • 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...

  • Director Regulatory Affairs and Quality

    vor 1 Monat

    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...

  • 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...

  • Regulatory Affairs Adviser

    vor 3 Wochen

    Hamburg, Deutschland Shell Vollzeit

    **The Role**: Are you a strategic thinker and that would like to learn about trading, regulation and market design? If so, we have the role just for you, in either London or Hamburg to kick start your career in the energy sector. **Where you fit in** The EU and German regulatory frameworks for gas are rapidly evolving in response to the challenging energy...

  • 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...