Quality and Regulatory Affairs Manager

3 days ago

Copenhagen, Copenhagen, Denmark Corti Full time

There is no quality healthcare without a quality dialogue. Today, that dialogue is broken; we need you to help us fix it.

Doctors and nurses across the world are facing unprecedented challenges. When we meet them, they're dealing with heavy workloads, extensive paperwork, and the pressure of performing well, which in healthcare, can have dire consequences. This system is gradually undermining the passion and autonomy of our dedicated healthcare professionals, who entered this field to provide care, not to clerk.

Corti has built the world's premier AI assistant for healthcare providers. It listens in during patient dialogue, takes notes, writes summaries, journals and does quality assurance. When information is missed, or risk is high, it offers nudges and prompts to help steer the dialogue back on the right path. Entire countries trust Corti to deliver better healthcare, and our AI has already helped millions of patients, but we are just getting started.

If you enjoy working in a fun, autonomous, and collaborative team, guided by shared values, and a willingness to act, iterate, and learn then come join Corti as the Quality and Regulatory Affairs manager and help us scale to the next level.

In this role you will ensure that our products and services meet the highest standards of quality and compliance and that we make a successful application for medical device approval. You will develop and implement quality management systems, assess and mitigate risks, create technical documentation, assess and apply for medical device approval in several markets, and support the VP of Governance and Market Access in implementing best practice methods and standards.

What will you do?

  • Develop and maintain quality and risk management systems to ensure compliance with relevant regulations and standards.

  • Conduct risk assessments and develop risk management strategies to mitigate potential hazards.

  • Implement and monitor processes for continuous quality improvement.

  • Support internal audits and inspections to assess compliance with quality standards and regulatory requirements.

  • Collaborate with cross-functional teams to address quality issues and drive corrective actions.

  • Stay updated and assess industry regulations and best practices to ensure Corti's compliance and adherence, with a focus on medical device assessment.

  • Actively promote a quality culture and regulatory requirements awareness.

  • Lead the medical device application process in several markets.

  • Support the VP of Governance and Market Access in implementing best practices methods and standards.

You'll thrive in this role if you have:

  • A Problem-Solving Mindset - You should be proactive in identifying areas for improvement and be able to develop innovative solutions to mitigate risks and enhance overall quality processes.

  • A Team Player Mentality - Collaboration is fundamental in this role. You'll work closely with various teams across the organization to implement quality initiatives and manage risks effectively.

  • Excellent verbal and written communication skills.

  • You have a ton of drive and the ability to thrive in a high-paced environment like Corti.

  • Regulatory Compliance Knowledge - Familiarity with industry regulations and standards related to medical devices, quality management and risk assessment is essential.

What background we're looking for:

  • Ideally, you have at least 2 years of experience in quality management, risk management and medical device regulation, preferably within our industry or a related field.

  • Familiarity with some of the regulatory relevant requirements, standards and guidelines.

  • We implement AI regulation, Medical device regulations, Privacy regulation, ISO standards (13485, 14971, 27001, 42001, 62304, 62366, etc.), GMLP, NIST AI RMF, etc.

  • Corti is already compliant / certified with GDPR, HIPAA, SOC2, FedRAMP, BSI C5, UK Cyber Essentials, UK DSPT, UK DCB0129, etc.

  • Experience in conducting risk assessments, developing risk mitigation strategies, and implementing risk management frameworks.

  • Experience in medical device assessment by MDR and FDA's regulations and the application process in the EU and US markets.

  • Education: Bachelor's degree in a relevant field required, Masters degree preferred. Additional certifications relating to quality and risk management systems and MDR PRRC role qualification preferred.

  • Demonstrated understanding of quality and risk management principles, methodologies, and tools (e.g. FMEA, root cause analysis).

Practicalities

  • This is a full-time position, starting as soon as possible.

  • You will be reporting to the VP of Governance and Market Access.

  • The work location for this position is preferred in Copenhagen (hybrid).

  • Yearly trip with the entire company - We went to Portugal last year

  • Investment in learning & developing you and your career.

  • Paid parental leave.

  • Company pension scheme.

  • Health insurance.

  • You will join a multinational team passionate about revolutionizing healthcare.

KPIs

  • High compliance audit scores.

  • Reduction in risk exposure.

  • Implementation of process improvements.

  • Cost savings or revenue generation.

Who are you as a person

  • You are energized by purpose.

  • You prefer truths over comfortable illusions.

  • You don't want a job where you watch the clock, but one where you make it count.

  • You are looking for a community of people equally as dedicated.

  • You embrace the pace of startup life.

Ready to dive into the world of Corti? Hit that 'Apply' button, and let's start working together on reshaping the dialogue in healthcare, making a real difference for millions of patient outcomes around the world.

Bringing in top talent from all backgrounds is crucial in our pursuit to improve the world of healthcare. We encourage applications from all people and do not discriminate based on race, religion, national origin, gender, sexual orientation, age, and/or disability status.

At Corti, experience comes in many forms, and we're passionate about creating teams with a multitude of perspectives If you believe your experience is close to what we're looking for but not an exact match, we still hope you'll consider applying

#J-18808-Ljbffr

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