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Regulatory Compliance Specialist
Il y a 2 mois
Job Title: Senior Quality Management Professional
Company: Balt
Location: Global
Job Type: Full-time
Industry: Medical Devices
Job Description:
Overview:
Balt is a leading medical device company that has been at the forefront of innovation for 45 years. We are seeking a highly experienced Senior Quality Management Professional to lead our Quality Systems team and ensure compliance with regulatory requirements.
Key Responsibilities:
- Develop and implement Quality Systems to ensure compliance with regulatory requirements, including ISO 13485:2016 and the European Medical Device Regulation (MDR)
- Lead audits and inspections, including internal and external audits, and ensure corrective actions are implemented
- Collaborate with cross-functional teams to develop and implement process improvements and ensure compliance with regulatory requirements
- Provide training and support to stakeholders on Quality Systems and regulatory requirements
- Participate in Management Reviews and provide input on Quality Systems and regulatory compliance
- Develop and maintain Quality Systems documentation, including procedures, work instructions, and records
- Ensure compliance with regulatory requirements, including reporting and record-keeping
Requirements:
- Master's degree in a scientific discipline
- Minimum of 7-10 years' experience in Medical Device Industry (Quality, Regulatory or related function)
- Fluent in English
- Excellent technical written and verbal communication skills
- Experience with creating/integrating Quality Systems
- Experience with Transitional MDR requirements implementation
- Strong knowledge of ISO 13485:2016 and European MDR
- Lead auditor certification to ISO 13485:2016 is ideal
What We Offer:
Balt offers a competitive salary and benefits package, as well as opportunities for professional growth and development.
