DESCRIPTION
In 2020, Clue will bring a Medical Device to women and people with menstrual cycles so that they can make good choices for themselves. We are looking for a Quality and Compliance Manager, with experience with Software as a Medical Device (SaMD) to play a pivotal role in bringing Clue’s new medical device from concept to commercialization. The role will ensure that the BioWink operations comply with regulatory requirements and provides people who menstruate with a high quality, reliable and clinically effective product.
ROLE
Quality Management
- Named Person Responsible for Regulatory Compliance, covering:
- Ensuring conformity of the Clue App to the BioWink Quality Management System, the EU Medical Device Regulation, and FDA Quality System Regulation (21 CFR 820).
- Ensuring compliance with Post-Market Surveillance (PMS).
Regulatory Compliance
- Manage further regulatory applications and authorised representatives in new markets
- Ensuring compliance with the Incident Reporting obligations to all regulators
- Respond to safety queries from regulatory authorities
Internal Audit
- Perform internal audits and technical information reviews to ISO 13485 standard.
- Responsible for providing recommendations and implementing action plans for continuous improvement.
Risk Management
- Maintain Risk Management files including all software development and post-market requirements.
- Collaborate with cross functional teams to analyse, control and evaluate product related risks as per ISO 14971 Risk Management for Medical Devices.
REQUIREMENTS AND DESIRED SKILLS
- Familiarity with agile software development; the different software engineering disciplines and software testing practices (however, this is not a QA Engineering role).
- You enjoy establishing and optimising a operating procedures together with a wider team, enabling your co-workers to understand the Why and What of quality assurance procedures in a regulated environment
- Your bring relevant experience of 5+ years plus, ideally 2-3 years in the medical device or similar medical industry
- Bachelor’s degree in engineering, computer science, life-sciences or related fields
- Excellent leadership skills, conflict resolution, assertiveness, negotiation and influence management
- Excellent written and verbal communication skills in English, further languages are a bonus
BENEFITS
We believe personal growth is essential for professional growth which is why we offer all the standard benefits, plus some that are uniquely Clue.
- Care for your body and mind with free weekly yoga and a free on-site therapist
- Work your way in our child-friendly and dog-friendly office. We’ll help with relocation if you’re not already in Berlin.
- Five weeks of paid vacation each year, a competitive salary, participation in our all-employee option pool, and the option to join the company pension plan.
Clue is committed to providing an environment of mutual respect, where equal employment opportunities are available to all applicants and team members. Our users are global and multicultural—and we want our team to reflect this. If you need assistance or an accommodation due to a disability, please contact us.