RA Engineer
vor 1 Woche
Company:
Regen Lab SA based in Le Mont-sur-Lausanne.
Join our dynamic team at a top-notch medical device company, where innovation and excellence are at the core of our mission to enhance healthcare on a global scale. With a dedicated group of professionals, we are devoted to creating state-of-the-art medical devices that have a positive impact on the lives of patients.
RA Engineer
Position Overview:
We are looking for a skilled QA/RA Engineer to join our team. In this role, you will be accountable for ensuring the quality and regulatory compliance of our medical devices throughout their lifecycle. Working closely with diverse teams, you will implement quality management systems and regulatory strategies to aid the successful development and market launch of our products.
On-site position.
Responsibilities:
- Maintain product documentation, such as design history files and technical files, to guarantee compliance with regulatory standards.
- Conduct risk assessments and offer guidance on risk management activities during product development.
- Assist in the preparation and execution of regulatory submissions, including 510(k) submissions, CE marking applications, and other necessary filings.
- Participate in projects focusing on QMS enhancements and product development in compliance with regulatory standards, including FDA QSR, ISO 13485, and other relevant regulations.
- Lead internal audits and assessments to ensure adherence to QMS requirements and pinpoint areas for enhancement.
- Work collaboratively with diverse teams to provide direction on quality and regulatory requirements, ensuring alignment with business goals.
Qualifications:
- Bachelor's degree in engineering or a related field; advanced degree preferred.
- Minimum of 3 years of experience in quality assurance and regulatory affairs within the medical device industry.
- Sound knowledge of medical device regulations, including FDA QSR, ISO 13485, EU MDR, and other global regulations.
- Experience with risk management methodologies, such as FMEA and risk analysis.
- Outstanding communication and interpersonal skills, collaborating effectively with different teams.
- Detail-oriented with strong analytical and problems-solving skills, capable of managing multiple tasks efficiently.
Why Join Us:
- Chance to collaborate with a dedicated team striving to make a positive impact on healthcare.
- Opportunities for professional growth to enhance your skills and advance your career in quality assurance and regulatory affairs.
- Supportive and collaborative work environment where your efforts are appreciated and respected.
If you are a motivated and detail-oriented engineer passionate about quality and regulatory affairs in the medical device sector, we encourage you to apply for this rewarding opportunity. Share your resume and cover letter highlighting your qualifications and experience, and join us in our mission to advance healthcare globally. We eagerly await your arrival to our team.
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