Quality and Regulatory Affairs Specialist (12 months)

AliveDx is seeking a Quality & Regulatory Affairs Specialist to join our Regulatory Affairs department based in Eysins, Switzerland. This is a full-time and temporary position for 12 months.

YOUR MISSION

Reporting to the Head of Regulatory Affairs, the Quality & Regulatory Affairs Specialist is responsible for delivering end to end regulatory package under ODM-Distributor scheme in compliance with established quality management system, overseeing (but not limited to) initial compilation of design control evidences, supplier management, incoming inspection and product release process, product submission, post-market surveillance, vigilance and associated reporting.

The Quality & Regulatory Affairs Specialist is also responsible for maintaining product and site regulatory & quality compliance to maintain license/registration once granted and supporting other regulatory and quality affairs team members as needed, including training and guidance as appropriate.

 As part of this team, your main responsibilities will include:

• Preparing and compiling regulatory documentation, coordinating and executing regulatory submission in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Medical Device Approvals (510(k)), and other country requirements as appropriate.
• Advising AliveDx staff and project team members on data and information required for successful license applications and coordinating their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
• Ensure Quality Assurance release of incoming goods, intermediate and final product obligations for AliveDx Suisse SA.
• Ensure Supplier management obligations for AliveDx Suisse SA.
• Ensure Post-market surveillance obligations for AliveDx Suisse SA.
• Ensure Vigilance reporting obligations for AliveDx Suisse SA.
• Be a point of contact for regulatory & quality compliance issues.
• Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
• Evaluate Product/Processes Non-Conformances, determine whether their need to be reported to the Competent Authorities.
• Support QMS organization during regulatory inspections or certifications audits.
• Perform any other duties as reasonably requested from the Company from time to time.
• Conduct all duties in compliance with company Quality Management System and cGMP, GCP and ISO13485 requirements.

YOUR COMPETENCIES

• Master degree or equivalent in life sciences and 10 years of experience in a regulatory/quality role.
• Experience in medical device / IVD / biotech industry.
• Experienced in meeting with, making presentations to, and negotiating with regulators.
• Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, CMDR, etc..).
• Specialist knowledge of vigilance processes for US, EU and other jurisdictions as appropriate (MDR, MEDDEV 2.12, etc.).
• Comfortable at directing actions internally and with suppliers.
• Effective time management and prioritisation skills.
• Sense of urgency.
• Ability to self-motivate.
• Ability to work in an international team in a fast paced changing environment.
• Great attention to detail with a thorough and methodical approach to work.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Fluent in English

WHAT WE OFFER

• A highly dynamic and growing environment.
• An opportunity to live your passion for an intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
• A flexible working environment where applicable and a range of core and flexible benefits, ranging from lunch allowance support, additional annual leave, cycle to work scheme, technology and access to marketplace discounts.

Interested? We invite you to send your application, including your resume and any other relevant documents. We look forward to exploring your potential contributions to AliveDx.

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, religion/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.