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Director of Regulatory Affairs
3 months ago
- Work with cutting edge solutions and advanced technologies
- Join a company who has a meaningful and positive impact on patients' lives
About Our Client
Our client is a a biotechnology company that specializes in developing and manufacturing a number of medical device focused products that contribute to life changing technologies, research and developmental biology. Their products are known for enhancing precision, efficiency, and outcomes in complex biological processes.
Job Description
- Quality Management System (QMS): Develop, implement, and maintain the company's QMS to ensure compliance with industry standards and regulatory requirements.
- Regulatory Compliance: Oversee regulatory compliance activities, ensuring that all products meet FDA, ISO, and other international regulatory standards.
- Audit and Inspection: Lead internal and external audits and inspections, addressing any findings and implementing corrective actions as needed.
- Document Control: Manage the document control system, ensuring all quality and regulatory documentation is accurate, up-to-date, and compliant.
- Continuous Improvement: Drive continuous improvement initiatives within the quality and regulatory functions to enhance product quality and operational efficiency.
- Cross-Functional Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, and clinical affairs, to ensure quality and regulatory requirements are integrated into all aspects of product development and production.
- Training and Development: Develop and conduct training programs for employees on quality and regulatory standards and best practices.
- Risk Management: Identify and manage risks related to product quality and regulatory compliance, implementing mitigation strategies as necessary.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The Successful Applicant
- Education: Bachelor's degree in a related field (e.g., engineering, life sciences). Advanced degree preferred.
- Experience: Extensive experience in quality assurance and regulatory compliance within the medical device industry.
- Knowledge: Strong understanding of FDA regulations, ISO standards, and other relevant regulatory requirements such as cGMP/Quality System Regulations (QSR), International Standards for Organization (ISO), Medical Device Single Audit Program (MDSAP) and EU Medical Device Regulation (2017/745),
- Skills: Excellent leadership, communication, and problem-solving skills. Ability to manage multiple projects and priorities effectively.
- Certifications: Relevant certifications such as CQE (Certified Quality Engineer) or RAC (Regulatory Affairs Certification) are a plus.
- Expertise and proficiency authoring FDA and other regulatory submissions (Pre-submissions, 510(k), PMA, Technical Files/Design Dossier, etc.).
What's on Offer
Innovative Environment: Work with cutting-edge technologies in the treatment of atrial fibrillation.Impactful Role: Play a crucial role in ensuring the safety, efficacy, and compliance of life-saving medical devices.Career Growth: Opportunities for professional development and advancement within a dynamic and growing company.Collaborative Culture: Join a collaborative and dedicated team committed to improving patient outcomes through innovative medical solutions.Competitive compensation and benefits
