This role is open to candidates residing in European Union (EU) countries only. Also note that depending on the country, we can offer either an employment contract or a freelancing consulting agreement.
In case you would be interested, please attach your CV in English.
A Little bit about us
VarSome.com is the world’s leading website for professional human genetics. With more than 4 000 citations in scientific papers, 60 000 registered professional users, we are seeking to bring together all the human expertise in molecular genetics. VarSome Clinical is a comprehensive decision support software platform for genetic testing.
VarSome is created by Saphetor, a Switzerland-based precision medicine company with offices in Lausanne, Boston, and Athens, using bioinformatics to apply human genome data to improve health and lives worldwide.
Saphetor is pioneering the use of big-data sequencing technology, such as exome and whole-genome sequencing, for clinical practice. We are involved in both clinical research and diagnostics, providing our clients with quality analysis and interpretation of next-generation DNA sequencing (NGS) data. All our services are provided over the web, and our VarSome.com website is the world’s prime reference for genetic variant interpretation.
The Opportunity
We are looking for an RAQA Manager who will report directly to the COO and lead our Regulatory Affairs and Quality Assurance activities. Under the direction and control of the RAQA Manager will be the Quality and Regulatory team, which currently consists of 1 person.
The role of the RAQA Manager is to ensure regulatory compliance with our platform's applicable requirements pertaining to in vitro diagnostic medical devices software.
In addition to compliance with our platform, the RAQA Manager will supervise our ISO 13485 compliant quality management system and our ISO 27001 Information Security Management System and ensure our processes are aligned to our business objectives. The activities will be conducted with the support of external specialists (Veranex) when needed.
Key Responsibilities
Regulatory Affairs:
- Ensure constant compliance to the (rapidly changing) local requirements for in vitro medical device software, develop regulatory strategies and maintain certification, clearance and market approvals in all regions where we operate (e.g. IVDR in Europe, FDA requirements in US, etc).
- Maintain our regulatory technical file that is used for conformity assessment, clearance process as well as inspection.
- Manage the Post Market Surveillance activities, including vigilance.
- Assess the need for local regulatory registrations and act accordingly.
- Identify appropriate regulatory bodies and manage the market approval process in each region where we expand our services.
- Ensure full compliance with data protection regulations (e.g., GDPR in Europe, HIPAA in US)
- Answer requests from prospects / customers on RAQA topics.
- Develop internal awareness on regulatory aspects, typically through company-wide training on data protection, IVDR, FDA, ISO, etc. requirements.
- Serve as Data Protection Officer and FDA Correspondent
Quality Assurance:
- Support all stages of the software product development process according to the IEC 62304 and IEC 82304: Design Planning, Design Control, Verification, Validation, Design Transfer, and Release.
- Maintain our existing ISO 13485 (QMS) and ISO 27001 (ISMS) certifications.
- Manage our internal audit program, as well as audits and inspections from regulatory bodies.
- Manage the KPI, the process reviews and the management review.
- Administer and manage supplier qualification activities and monitor suppliers’ performance.
- Update our policies and procedures as needed to ensure full compliance with the various regulations
- Manage the CAPA process and ensure corrective actions are established and that root- cause elimination is completed for identified issues.
- Manage the Change control process.
- Oversee Customer Complaint process.
Managerial responsibilities:
- Manage the team (goal setting, task allocation and progress, career development) and ensure work efficiency.
- Internal stakeholders' consulting and management are needed to ensure all the RAQA requirements are properly implemented.
- Develop a yearly target budget. Manage QA & RA expenditure against budget.
- Exhibit skills in project management, leadership, communication and presentations.
- Identify issues and minimize regulatory risks through creative problem solving.
What you will bring:
Tech skills:
- 5+ years in Quality, and Regulatory Affairs experience related to medical devices/in vitro diagnostic medical software devices, preferably with the responsibility of managing others.
- Strong experience of the medical device software development process.
- Good understanding of Data Privacy and Information Security related requirements associated with online web platforms.
- Experience with FDA and EU diagnostic/medical device and facility registrations.
- Engineering or scientific degree or demonstrated proficiency through Regulatory Affairs Certification (RAC). An advanced degree relevant to laboratory testing or biomedical product development would be a plus.
- Ability to read, understand and interpret medical devices, FDA and EU regulations and requirements.
- Excellent English communication skills are required, both written and verbal. Write procedures; perform presentations to staff and management.
- Ability to learn about genetics will be critical to the success of this role and enable you to better understand the cutting-edge medical services we offer.
People skills:
- Ideally 2+ years management experience
- Very good communication skills – especially the ability to listen and communicate your thoughts clearly.
- Creative problem solving skills for regulatory strategies.
- Ability to enroll others in quality and compliance initiatives.
- Ability to work independently and as part of a team
- Organizational and planning skills, including action oriented, focus urgency and driving for results
- Great capacity for relational adaptation which will allow you to integrate quickly into a young dynamic team
Your career journey with us includes, among others:
- A great position in a fascinating healthcare growth domain, at the cutting edge of technology and research.
- A competitive compensation package
- Work from home: The Saphetor team is located in several European countries and mainly works from home. Everybody speaks fluent English. The company is well-experienced in coordinating a regionally distributed team using an Agile workflow.
- Endless learning opportunities, while transferring new technologies from academics to clinical practice all over the world.
Saphetor is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and our employees, regardless of race, color, religion, national origin, age, sex, medical condition or disability, sexual orientation, gender expression, or marital status.
