Regulatory Compliance Specialist
7 days ago
Company Overview
Verathon, a leading medical device company, focuses on delivering high-quality products that meet the evolving needs of healthcare providers. With a strong commitment to customer satisfaction, the company has become a trusted partner in the industry.
The company's product portfolio includes innovative solutions for bladder volume measurement and airway management, addressing critical unmet needs in patient care. Verathon's products have raised the standard of care for patients worldwide.
Job Description
As a Compliance Engineer in Regulatory Affairs, you will play a crucial role in defining and maintaining compliance engineering requirements for product design and testing. You will be responsible for preparing and maintaining technical documentation files according to European Medical Device Directive (MDD 93/42/EEC) and European Medical Device Regulation (MDR) 2017/745.
Responsibilities
- Define compliance engineering requirements for product designs, updates, and testing
- Manage and maintain the worldwide standards database
- Liaise with external test houses and notified bodies on compliance topics
- Author and maintain product technical documentation files
- Provide support for external audits and internal quality management system audits
Required Skills and Qualifications
To succeed in this role, you must possess:
- Bachelor's Degree in a Scientific or Engineering field
- Minimum 5 years' experience in compliance and/or quality system activities in a QSR/ISO 13485 Quality Management System and MDSAP audits
- Knowledge of regulatory requirements including GMPs, MDD/MDR, CMDR, TGA, ANVISA, and PMDA
- Demonstrated experience with US, Canadian, and international product safety standards
Benefits
As a full-time employee at Verathon, you will enjoy a competitive salary range, comprehensive benefits package, and opportunities for professional growth and development.
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