Are you a detail-oriented professional with a passion for ensuring compliance in the medical device industry? A Premier Medical Company, located in Philadelphia, PA, is seeking an experienced Medical Device Regulatory Compliance Manager to lead and manage their regulatory compliance efforts, ensuring that all products meet the necessary legal and quality standards.
About the Company:
Our client is a leader in the medical device industry, dedicated to delivering innovative solutions that enhance patient care. With a commitment to quality, safety, and regulatory excellence, they are looking for a regulatory expert to join their team and play a pivotal role in maintaining compliance across their product lines.
Responsibilities of the Medical Device Regulatory Compliance Manager:
As the Medical Device Regulatory Compliance Manager, you will be responsible for:
- Regulatory Strategy: Developing and implementing strategies to ensure compliance with FDA, ISO, and other global regulatory standards.
- Documentation Management: Overseeing the preparation and submission of regulatory documents, including product registrations, certifications, and audits.
- Compliance Monitoring: Monitoring and ensuring compliance with all regulatory requirements throughout the product lifecycle.
- Cross-Functional Collaboration: Working closely with R&D, quality assurance, and manufacturing teams to integrate compliance practices into every stage of product development.
- Regulatory Audits: Leading and managing external and internal audits to ensure ongoing regulatory compliance and readiness.
- Continuous Improvement: Identifying opportunities for improving compliance processes and staying up-to-date with changes in regulations and industry standards.
Qualifications:
To excel as the Medical Device Regulatory Compliance Manager, candidates should possess:
- Extensive experience in regulatory compliance management within the medical device industry.
- Strong understanding of FDA regulations, ISO standards, and other relevant global regulatory frameworks.
- Excellent attention to detail and the ability to manage complex documentation processes.
- Proven experience leading regulatory audits and interactions with regulatory bodies.
- Strong communication skills, with the ability to collaborate with cross-functional teams and influence decision-making processes.
- A degree in regulatory affairs, life sciences, or a related field. Regulatory Affairs Certification (RAC) is a plus.
How to Apply:
If you’re an experienced regulatory compliance professional ready to take on a critical leadership role in the medical device industry, we encourage you to apply. Submit your resume and a cover letter outlining your qualifications and vision for the role. Looking to advance your career in regulatory compliance? Join this Premier Medical Company and contribute to the development of life-saving medical technologies. Explore our current opportunities and apply today to make an impact in healthcare!
