RA Engineer
vor 3 Wochen
Company:
Regen Lab SA based in Le Mont-sur-Lausanne.
Join our dynamic team in at a leading medical device company, where innovation and excellence drive our mission to improve healthcare worldwide. With a dedicated team of professionals, we are committed to developing cutting-edge medical devices that make a positive impact on patients' lives.
RA Engineer
Position Overview:
We are seeking a talented RA Engineer to join our team. In this role, you will be responsible for ensuring the quality and regulatory compliance of our medical devices throughout the product lifecycle. You will work closely with cross-functional teams to implement quality management systems and regulatory strategies to support the successful development and commercialization of our products.
On site working.
Responsibilities:
- Maintain product documentation, including design history files and technical files, to ensure compliance with regulatory requirements.
- Conduct risk assessments and provide guidance on risk management activities throughout the product development process.
- Support the preparation and execution of regulatory submissions, including 510(k) submissions, CE marking applications, and other regulatory filings as needed.
- Contributing to projects related to QMS improvement and product development in accordance with regulatory requirements and standards, including FDA QSR, ISO 13485, and other applicable regulations.
- Lead internal audits and assessments to ensure compliance with QMS requirements and identify opportunities for improvement.
- Collaborate with cross-functional teams to provide guidance on quality and regulatory requirements, ensuring alignment with business objectives.
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.
- Strong knowledge of medical device regulations, including FDA QSR, ISO 13485, EU MDR, and other international regulations.
- Experience with risk management methodologies, including FMEA and risk analysis.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Detail-oriented with strong analytical and problem-solving skills, with the ability to prioritize and manage multiple tasks effectively.
Why Join Us:
- Opportunity to work with a passionate and dedicated team committed to making a difference in healthcare.
- Professional development opportunities to expand your skills and advance your career in quality assurance and regulatory affairs.
- Collaborative and supportive work environment where your contributions are valued and recognized.
If you are a motivated and detail-oriented engineer with a passion for quality and regulatory affairs in the medical device industry, we invite you to apply for this exciting opportunity. Submit your resume and cover letter outlining your qualifications and experience and join us in our mission to improve healthcare worldwide. We look forward to welcoming you to our team
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