Regulatory Compliance Specialist
il y a 3 jours
At Snitem, we are seeking a highly motivated Regulatory Compliance Specialist to oversee all aspects of our Quality Management System and product regulatory compliance. As a key member of our team, you will be responsible for ensuring that our medical devices meet the highest standards of quality and safety.
Key Responsibilities:
Develop and maintain the Quality Management System to ensure compliance with applicable regulations.
Manage NC, CAPA & Complaint process: Drive and collaborate with cross-functional team members to develop action plans and adhere to process phase timelines.
Manage Quality Post-market activities: Monitor product performance, providing data to support decisions regarding the safety and effectiveness of the product.
Participate in internal and external regulatory audits.
Provide regular training to the team and foster a culture of compliance and continuous learning within the company.
Qualifications:
3+ years experience in QARA for medical devices.
Master's degree in engineering, biomedical sciences, or in the field of Regulatory Affairs or Quality assurance.
Strong knowledge of regulations and standards related to medical devices such as (UE)2017/745 MD regulation, QMS standard & regulations (ISO 13485, 21 CFR), and product-related standards such as ISO 14971, IEC 62366, IEC 62304, and IEC 82304-1.
You can work autonomously with strong analytical and problem-solving skills and with meticulous attention to detail.
Ability to work collaboratively in cross-functional teams with a great team spirit.
Strong French and English language skills.
What We Offer:
Competitive salary and benefits package.
Opportunity to work with a dynamic and growing company in the medical device industry.
Collaborative and supportive work environment.
Professional development opportunities.
How to Apply:
If you are a motivated and experienced Regulatory Compliance Specialist looking for a new challenge, please submit your application, including your resume and cover letter, to [insert contact information].
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