Regulatory & Quality Assurance Administrator Lisboa

Regulatory & Quality Assurance Administrator
Lisboa
Lisboa, Lisboa, Portugal

Regulatory & Quality Assurance Administrator

Beats Medical is the global leader in digital assessments, therapies, and biomarkers for Central Nervous System (CNS) Conditions and Rare Diseases. Founded in 2012, we leverage
- edge technology and
- sector expertise to transform the management of CNS conditions, delivering
- changing innovations across 30+ countries. Partnering with leading pharmaceutical companies and patient advocacy groups, we are on a mission to unlock the breakthrough treatments and therapies of the future.

This is a chance to join a growing international company dedicated to transforming lives and healthcare through technology. In this role you will work within a highly engaged team based in Dublin and Lisbon, comprising of commercial, developers and designers with embedded product and quality assurance responsibilities.

What are we looking for?

As we continue to expand, we are seeking a Regulatory & Quality Assurance Manager to lead our ongoing certification, compliance and reimbursement functions, working alongside our product developers, research partners, clinicians and commercial team to deliver the highest quality standards for our Software as a Medical Device platform.

Key Responsibilities

• Ongoing development, implementation and maintenance of a robust and fully compliant quality system in accordance with ISO 13485
• Updating and maintaining established, independently reviewed QMS for upcoming MDR submission and ensuring long term certification maintenance
• Leading annual external audits of QMS for independent certifications, including responsibility for audit readiness, team training and upskilling, internal reviews and quality checks
• Engaging with key decision makers and external partners to ensure successful management of FDA requirements and subsequent reimbursement pathways
• Leading strategy to leverage established regulatory approvals and new approval pathways to enable product reimbursement in multiple jurisdictions, with in depth knowledge of requirements, processes and operations of such reimbursement channels
• Ensuring
  - functional adherence to best practices based on our established Quality Management System requirements for medical devices
• Supporting business operations by managing a range of administrative functions, ensuring seamless
  -
  - day execution of key processes
• Managing quality processes across the software development lifecycle, working closely with design, product, clinical and data teams to ensure best practice regulatory and quality principles for long term success
• Software application testing and reporting to ensure product quality requirements are consistently met, tracked and communicated
• Supporting quality related activities for Software as a Medical Device development, ensuring controls are implemented, maintained and documented
• Overseeing ongoing product verification and validation activities to ensure organisational and external regulatory compliance
• Supporting research and development strategies to ensure project outputs align with regulatory requirements and quality assurance goals
• Supporting a
  - driven working environment with focus on delivery of quality assurance standards and continuous improvement
• Providing guidance on regulatory, quality and safety issues to a cross functional team spanning development and commercial

Skills & Qualifications

• 4+ years of Quality Assurance and Compliance experience, with a quantifiable record of achievement in maintaining and improving a Quality Management System in compliance with medical device standards
• ISO13485 Lead Auditor Certified with a proven record of independently managing external audits and maintaining ISO standards
• Proven ability to work independently in a dynamic, growing entrepreneurial environment
• Strong interpersonal skills, with the ability to communicate with people working in all departments. Excellent oral, written and presentation communication skills, fluent in written and spoken English
• Impeccable organisational skills, with a keen eye for detail, strong documentation skills, and experience in ensuring that all operations are meeting security and quality standards
• Knowledge of ISO9001 and risk management and regulatory procedures pertaining to quality assurance of software/technology
• Practical experience with FDA certification submission process and approval pathways
• Understanding of requirements of EU MDR and EUDAMED as it pertains to software as a medical device
• Successful record of working with SDLC (software development life cycle) principles
• Previous experience in software testing, validation and verification activities

What We Offer

• A competitive salary package.
• The opportunity to shape the quality, regulatory and reimbursement strategy of a scaling digital health startup as we expand our impact in new markets and indications.
• A collaborative, innovative, and dynamic work environment.
• Opportunities for personal and professional growth as the company scales.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Information Technology

Industries

Medical Device