Regulatory and Quality Leadership Professional
2 weeks ago
We are seeking a seasoned professional to lead our regulatory and quality efforts for implantable medical devices. This role will be responsible for managing submissions and implementing a Quality Management System (QMS) that meets FDA and EU-MDR requirements.
Key Responsibilities:
- Develop and implement a QMS for implantable medical devices.
- Define and manage regulatory requirements for FDA and EU-MDR submissions.
- Prepare and present quality and regulatory documentation to regulatory bodies.
- Oversee regulatory audits and ensure compliance with submission deadlines.
Requirements:
- Proven experience in leading the setup and implementation of a QMS for medical devices.
- Leadership experience in defining regulatory requirements for medical devices.
- Extensive experience leading regulatory submissions to FDA and EU-MDR.
- Direct experience with Class III implantable devices, specifically leading the submission process.
Preferred Skills:
- Experience with audits, particularly FDA and EU-MDR related.
- Familiarity with preparing for regulatory audits, including upcoming audits and submission deadlines.
Benefits:
- Competitive hourly rate: $40.00 to $60.00 per hour.
- Comprehensive benefit package, including medical, dental, vision, life insurance, short-term disability, and a 401K plan.
- Opportunities for professional growth and development.
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