Regulatory Compliance Specialist for Medical Devices
3 weeks ago
We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Floaid Medtech. This role will play a critical part in ensuring the development, implementation, and maintenance of our quality and regulatory programs.
About UsFloaid Medtech is an innovative medical device company driven by the vision of providing state-of-the-art technology to our nation while adhering to international standards. Our commitment to innovation, technology, and precision sets us apart, and we're looking for a seasoned professional to lead our regulatory efforts.
Key Responsibilities- Develop, implement, and maintain our Quality Management System (QMS) in compliance with ISO 13485, US FDA, EU MDR, CDSCO, and other applicable regulations.
- Act as the Person Responsible for Regulatory Compliance (PRRC).
- Provide regulatory advice to R&D, Marketing, and other departments to ensure alignment with global market requirements.
- Oversee and manage internal and external audits, including preparation, execution, and follow-up.
- Establish and maintain vendor relationships with a focus on quality standards.
- Lead CAPA, ECRs, and ECNs processes.
- Develop and deliver training programs on quality and regulatory requirements.
- Ensure regulated processes and systems are always inspection-ready.
- Collaborate with cross-functional teams to embed quality into product development and manufacturing processes.
- Support computer software validation (CSV) processes, including IQ/OQ/PQ protocols.
To be successful in this role, you'll need:
- A strong understanding of ISO 13485, EU MDR, US FDA, CDSCO, ICH, cGMP, and other global regulations.
- Experience hosting regulatory inspections and audits.
- Demonstrated expertise in computer software validation (CSV) and QMS implementation.
- Ability to prioritize and manage multiple projects with attention to detail.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Proven ability to establish and maintain strong internal and external partnerships.
- Highly independent, self-motivated, and capable of working effectively within diverse teams.
As a Regulatory Compliance Specialist at Floaid Medtech, you'll enjoy:
- An estimated salary range of $80,000 - $110,000 per year, depending on experience.
- A collaborative and innovation-driven work environment.
- Career growth and professional development opportunities.
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