SUMMARY OF POSITION:
Reporting to the Director of Strategic Sourcing, this is a 3-person team owning all aspects of quality assurance and regulatory compliance for our company. We have 6 sporting goods brands in our portfolio (Shock Doctor, McDavid, Cutters, Nathan, PEARL iZUMi, Glukos) that span across the regulatory requirements of ISO13485 (class 1 medical devices), SB707, SB54, FDA, EU Compliance and regulations as needed.
This role is primarily responsible for overseeing and improving the quality of products and services within the organization in order to improve our efficiency and profit by reducing waste and improving systems. This role is responsible for the efficient control of documentation required by the company, state, federal and international regulatory agencies. This includes product registrations, annual facility registrations, device listings, technical files and CE Certifications. Review and interpret new or proposed regulatory rules as they relate to company products and processes. Provide current knowledge and support to enable the company to operate within quality and regulatory guidelines.
ESSENTIAL FUNCTIONS:
Quality Assurance:
- Assist with maintaining the Quality Management System (QMS) to meet regulatory standards.
- Conducting internal and external audits to ensure compliance.
- Managing and reviewing quality documentation for assigned products/categories, including Standard Operating Procedures (SOPs).
- Ensuring compliance with relevant industry standards and regulations, such as ISO 13485 for assigned products/categories.
- Monitoring and analyzing quality metrics to identify trends and areas for improvement.
Regulatory Affairs:
- Staying informed about US and international regulatory requirements and changes in relevant jurisdictions for assigned products/categories.
- Managing regulatory registrations, notifications, and change requests.
- Ensuring compliance with regulatory requirements related to product development, manufacturing, and distribution.
- Working with internal teams and external consultants to navigate regulatory processes.
- Managing post-market surveillance activities, such as non-conformity reports, CAPAs (Corrective and Preventative Actions), complaints, and adverse events.
- Representing the company during regulatory inspections and audits.
Documentation and Reporting:
- Creating, reviewing, and managing quality and regulatory documentation for assigned products/categories.
- Preparing reports and presentations for management, regulatory agencies, and internal stakeholders.
POSITION SPECIFICS:
- This is a full-time position
- Typical work hours and days are Monday – Friday, 8:30 a.m. to 5:00 p.m.
- This position is based out of the Fountain Valley, CA office
- No travel is expected for this position.
- This position requires in-office attendance at least 4 day(s) per week.
PAY TRANSPARENCY:
- The Company is committed to fair, equitable, and transparent compensation. Final compensation will be determined by various factors such as your relevant work experience, education, certifications, skills, and geographic location.
- The salary range for this role in Fountain Valley, CA is $75,000.00 - $90,000.00
- In addition, you may be eligible for additional compensation, such as a bonus. Employees may also be eligible for a wide range of other benefits, including health & wellness benefits, retirement, time off, employee discounts, and others.
SUPERVISORY RESPONSIBILITIES:
- This position does not have supervisory requirements and/or responsibilities.
- Indirectly guides, motivates, and coaches team members to achieve goals and objectives.
- Indirectly manages team schedules, organizes workflow, and ensures tasks are completed efficiently, establishes clear expectations, deadlines, and performance standards for team members, and communicates information between management and employees, preparing reports, and providing updates.
REQUIRED EDUCATION & EXPERIENCE:
- Education: Bachelor’s degree in a technical or scientific field (e.g., engineering, biology, chemistry) or equivalent work experience.
- Minimum 5 years relevant experience.
- Working knowledge/experience with the following regulatory standards: ISO13485 (class 1 medical devices), SB707, SB54, FDA , EU MDR and EU PPE regulations
- Knowledge of CPSIA Requirements is desired.
- Knowledge of relevant regulatory frameworks and standards.
- Experience with auditing procedures and compliance management systems.
- Demonstrated experience in project/program management managing larger-scale projects and compliance requirements.
- Effective communication skills and adaptable communication style for interacting with team members, upper management and customers.
- Strong interpersonal skills to work with team members, customers, suppliers, etc.
- Time management and organizational skills for planning and executing both large and small projects and initiatives.
- Analytical and problem-solving skills for coming up with ideas to routine or complex problems.
- Working knowledge and comfort with using Microsoft Outlook, Word, Excel, PowerPoint, & Teams.
PHYSICAL DEMANDS/WORK ENVIRONMENT:
Candidate must be able to successfully perform the essential functions of this job with ability to: be in a stationary position 50% of the time; occasionally move about inside the office to access fine cabinets, office machinery (such as a calculator, copy machine, printer, etc.); constantly operate a computer; occasionally ascend/descend stairs; constantly position self to maintain files in file cabinets; the ability to communicate information and ideas so others will understand; must be able to exchange accurate information in these situations; the ability to observe details at close range (within a few feed of the observer); and frequently move boxes weighing up to 10 pounds across office for various needs. Ability to work in outdoor weather conditions if projects/opportunities arise. The noise level in the work environment is usually moderate.
