Regulatory Affairs and Quality Management Lead
Vor 2 Tagen
Make a positive impact in the global healthcare community with cutting-edge medical mixed reality technology.
About Us:
ApoQlar is a pioneering developer of medical mixed reality platforms that are revolutionizing the healthcare industry. 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.
We are a global company with offices in Miami, Poznan, Singapore, and our headquarters in Hamburg. We are dedicated to leveraging cutting-edge technology and innovative solutions to revolutionize the healthcare industry.
We are currently seeking an enthusiastic and motivated individual to join our team in Hamburg (onsite/hybrid) as a Regulatory Affairs and QMS Lead. 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:- 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).
- 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 practical FDA 510K application knowledge and a proven track record of associated products.
- Proficient knowledge of EU medical device regulations and Quality Management Systems for medical devices.
- Knowledge of MDSAP, ISO 13485, IEC 62304, and ISO.
- 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.
- 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.
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