As a Quality & Regulatory Affairs Expert, you will not only be a member of the team but will also be creating the future of medical technology. Your experience in Quality and Regulatory Affairs for SAMD, SiMD, and IVD medical devices is critical to improving developing technologies while assuring maximum safety and efficacy. This position goes beyond the typical job description; it offers the opportunity to transform patient care and enhance the lives of millions of people throughout the world.
As our specialist, you'll be part of a dynamic team that delivers projects for clients at the pinnacle of the healthcare business. These projects aren't just inventive; they're trailblazing, frequently straddling the border between compliance and forward progress. Your experience and insight will be crucial as we navigate these issues, ensuring that we stay on the right side of regulations while pushing the limits of what is possible.
In this role, you will contribute to creating innovative products that both our clients and patients will love. This is your opportunity to make a substantial impact in an industry where every advancement can mean saving lives and enhancing the quality of healthcare worldwide.
We are looking for bold individuals with a growth mindset who thrive in multidisciplinary teams, are passionate about developing others, and relentless in their pursuit of learning on the job. Your ability to inspire, lead, and innovate will not only drive client projects forward but also contribute to the professional growth of your team members. If you are someone who embraces challenges with enthusiasm, constantly seeks to expand your skillset, and enjoys being at the cutting edge of healthcare technology, you will find a fulfilling career path with us. Here, your contributions are not just valued—they are vital to our clients' mission of redefining patient care and advancing medical technology.
Optimizing Client QA/RA Processes:
- Your primary responsibility will be to assist clients in enhancing their Quality Assurance and Regulatory Affairs processes. This involves not just applying your expertise to make these processes more efficient and lean, but also ensuring they robustly meet quality and regulatory compliance. You will be directly impacting client success by streamlining their operations without compromising the integrity of their medical products.
End-to-End Oversight of Medical Device Development:
- You will take charge of overseeing the entire lifecycle of medical device development for our clients. This encompasses understanding their needs from the initial concept to market release. Your role involves conducting detailed inspections, audits, and providing strategic recommendations. This is not just about adherence to standards but about bringing a vision of excellence and innovation to every stage of development.
Architecting Design Control Framework:
- As an expert, you will be responsible for developing and maintaining a comprehensive design control framework that aligns with industry benchmarks such as IEC 62304 and AAMI TIR45. Your expertise will ensure that projects are not only compliant with international standards like ISO 13485 and FDA QSR but also set new benchmarks in medical device development.
- A minimum of 5 years’ experience in QA/RA in the medical device domain (SaMD/SiMD/IVD)
- A fervent advocate for quality and excellence in medical device.
- An enthusiastic learner, always seeking to expand knowledge and skills.
- Ability to thrive in the dynamic and agile environment.
- Understanding the key requirements and principles of Quality Management System.
- In-depth knowledge of medical device regulations, including US FDA and EU MDR, and familiarity with international quality and technical standards in the medical device domain (e.g. ISO 14971, ISO 13485, IEC 60601, etc. ).
- Proficient understanding of SaMD-specific standards like IEC 62304 and AAMI TIR45.
- Exceptional communication skills (English B2), coupled with the ability to build and maintain professional relationships.
- Outstanding organizational acumen, attention to detail, and a systematic approach to problem-solving.
Nice to have:
- A history of successful regulatory submissions for medical devices or co-authoring submission documents (EU MDD/MDR or FDA)
- A background in software, electrical engineering, or experience in leading such teams will be considered an asset.