DescriptionPosition SummaryAs the Director of Regulatory Affairs and Quality Assurance (RA/QA), this position is responsible for ensuring global leadership in RxFunction by influencing the creation of, and ensuring compliance with, the global regulatory requirements for the company's emerging medical device initiatives. This position will interact with the FDA, Notified Bodies, and other regulatory authorities as needed to develop the regulatory strategies and to manage all aspects of their execution regarding RxFunction products.
This position is responsible for ensuring the overall effectiveness of the regulatory compliance program and the quality management system (QMS) throughout the organization, including its ongoing conformance with quality certification standards. It reports to the VP of Technology and works with all critical functions of the organization.
Job ResponsibilitiesResponsibilities include, but are not limited to, the following:
Directs and oversees the RA/QA department.
• Ensures effective staffing, wages, and professional development.
• Provides leadership, supervision, and development opportunities to direct reports.
• Verifies performance of direct reports and making fair performance decisions.
• Prepares the annual department budget in coordination with the Finance department.
Secures market approvals for RxFunction products in target geographies.
• Develops, in collaboration with key stakeholders, the global regulatory strategy for RxFunction products and ensures its implementation.
• Identifies applicable regulations, standards, and guidance documents.
• Ensures compliant, complete, and accurate regulatory submissions to FDA and international regulatory authorities.
• Ensures that all supporting documentation is properly approved and maintained, whether or not a formal submission is required by FDA or another regulatory authority.
Ensures that high-quality RxFunction products are delivered to customers.
• Implements and maintains an effective QMS, including all required documentation.
• Ensures product quality throughout new product development, design transfer to production, production changes, and post-production activities.
• Makes the final decision on product quality holds and releases.
• Ensures that risk management evaluation and mitigation techniques are applied throughout product realization activities.
Serves as the Quality Management Representative.
• Ensures that processes needed for the OMS are documented and maintained.
• Reports to the leadership team on the performance of the OMS and any need for improvement.
• Ensures the promotion of awareness of OMS, regulatory and customer requirements throughout the organization.
• Prepares and leads Management Review meetings, which includes preparation and distribution of materials regarding the OMS performance relative to quality objectives.
Chairs the Cybersecurity Panel, which reviews and approves all cybersecurity risk assessments, mitigations, and residual risk justifications and escalations.
Maintains the highest levels of ethics and confidentiality.
Other duties and responsibilities may change or be assigned at any time with or without notice.
Required Qualifications- A Bachelor's degree in a related science or engineering discipline.
- 15+ years' experience in Regulatory Affairs and Quality Assurance within the medical device industry, with 5+ years of supervisory experience.
- Extensive knowledge of global regulatory requirements and market pathways for medical devices.
- Demonstrated understanding of ISO 13485, 21 CFR Part 820 and other applicable FDA medical device regulations.
- Experience in Design Assurance, Operations Quality, Risk Management, Regulatory Compliance, Complaint Handling, and Regulatory Reporting to Authorities.
- Proven track record of managing positive interactions with the FDA and other regulatory authorities with respect to inspection / audit results and obtaining market approvals.
- Strong leadership, verbal and written communication, and organizational skills.
- Experience working effectively with teams within an organization.
- Ability to travel up to 20% by car or plane.
Preferred Qualifications- MBA or a relevant advanced technical degree.
- Professional certifications through RAPS or ASQ (CMQ/OE, COE).
- Working experience with electronic quality management system (eQMS) software.
- Advanced expertise using MS Office applications such as Word, Excel, and PowerPoint.
Physical Requirements:• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to use a computer and communicate with others.
