Regulatory Affairs and Quality Management Lead
Vor 6 Tagen
We are seeking a highly skilled Regulatory Affairs and Quality Management Lead to join our team at apoQlar. As a key member of our Regulatory & Quality Management team, you will play a leading role in ensuring our medical mixed reality platform is in compliance with regulatory and statutory requirements.
Key Responsibilities- Develop and Lead Regulatory Strategy: Ensure compliance with applicable laws, regulations, and facilitate fast and efficient certification of new product developments.
- Maintain and Optimize QMS: Focus on specific processes such as change control, design controls, verification and validation, and risk management.
- Lead Regulatory Approval Processes: Globally coordinate and lead the regulatory approval processes.
- Develop Regulatory Responses: Create regulatory responses for questions from notified bodies, global regulators, and regulatory representatives.
- Implement Regulatory Requirements: Ensure compliance with EU MDR 2017/745 and other regulatory requirements.
- Lead Risk Management Activities: Collaborate with the risk management team through the life cycle of medical device software.
- Participate in Audits: Participate in and support external/internal audits and responses to audit findings.
- Ensure Compliance: Ensure compliance with current regulatory procedures and update procedures when new regulatory requirements are determined.
- Monitor Regulatory Requirements: Monitor new/revised applicable regulatory requirements, standards, guidance, and common specifications.
- Handle Serious Incidents: Handle serious incident and adverse event reporting.
- Ensure Effective Communication: Ensure effective communication with Notified Bodies and Regulatory Authorities.
- Ensure Marketing Compliance: Ensure marketing communication is according to regulatory requirements.
- Act as PRRC: Act as appointed Person Responsible for Regulatory Compliance.
- University Degree: University degree in biomedical science, engineering, pharmacy, or any other applied natural sciences.
- Professional Experience: 7+ years of professional experience including MDD/MDR and FDA submissions.
- Regulatory Knowledge: Proficient practical FDA 510K application knowledge and a proven track record of associated products.
- EU Medical Device Regulations: Proficient knowledge of EU medical device regulations and Quality Management Systems for medical devices.
- Software Lifecycle Processes: In-depth knowledge of Software Lifecycle Processes, including expertise in implementing the requirements of the IEC 62304 standard and AAMI TIR45 guidance.
- Software as a Medical Device: Extensive experience in Software as a Medical Device (SaMD), covering design controls, risk management, verification and validation, SOUP, and Software Configuration Management.
- QMS Maintenance: Demonstrated ability to maintain and streamline QMS for seamless use across the organization.
- Communication Skills: Strong analytical skills to evaluate product compliance and interpret regulatory guidelines.
- Collaboration: Ability to collaborate effectively with internal specialists and other external consultants.
- Language Skills: Fluency in English is a requirement, German is a huge plus.
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