REGULATORY AFFAIRS AT APPLIED

Applied Medical’s Regulatory Affairs team guides and supports the organization in maintaining compliance with regulations that govern how products are developed, tested, manufactured, and marketed. Regulatory team members have the responsibility of interpreting U.S. and international regulations, developing regulatory strategies, supporting rapid product enhancements, and utilizing customer feedback to address healthcare needs. As part of Applied Medical’s mission to bring affordable, high-quality devices to market, the Regulatory team works closely with in-house teams, as well as domestic and international customers, to distribute and sell our medical devices in more than 75 countries. The team focuses on quickly bringing new and enhanced products to patients.

QUALITY AT APPLIED

At Applied Medical, Quality team members are responsible for interpreting and implementing standards, procedures and regulations related to medical device manufacturing. The Quality team collaborates with many in-house teams, including Regulatory Affairs, Engineering and Clinical Development, to make sure Quality System (QS), Medical Device Directive (MDD) and other regulations are followed. Team members have exciting opportunities to work in Quality Assurance, Quality Control and Quality Systems as part of Applied Medical’s responsibility to bring safe, effective and high-quality products to the customers who need them the most.

LEARN MORE ABOUT APPLIED MEDICAL

“Not only does Applied Medical build superb medical devices; it builds careers. I was the 41st employee hired in 1990. Since then, I’ve spent time in every Engineering division, Documentation Control, Maintenance, the Prototype Shop, Automation, Mold Manufacturing, Quality Systems, and Regulatory Affairs. I’ve been here for 27 years. I could retire but I would miss the community!”

Frans V. - Team Member Since 1990

“The familial company culture, interdepartmental relations and camaraderie truly sets Applied Medical apart. You simply keep learning and growing with others’ wisdom and your own, while also helping to make a positive impact in local communities, as a team, through various community outreach programs and volunteer opportunities.”

Angelika P. - Team Member Since 2011

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JOIN OUR REGULATORY AFFAIRS & QUALITY TEAMS

Applied Medical’s Regulatory Affairs & Quality team members enjoy a fast-paced, challenging and collaborative work environment that allows for tremendous personal and professional growth. We invest heavily in the education and development of our team, providing opportunities for team members to explore different roles as they grow with our organization.

If you are passionate about working for a company that allows you to make decisions based upon what is right for the customer, patient, community, and environment, Applied Medical is the ideal place for you.

REGULATORY AFFAIRS & QUALITY AREAS OF OPPORTUNITY

Regulatory Affairs International

Responsible for supporting international distributors and OEM customers in meeting and maintaining regulatory and quality compliance, including new product registration; license amendments and renewals; foreign manufacturer registration; and Quality Management System requirements in international markets.

Quality Assurance

Responsible for implementing improvements to the product design and manufacturing processes; reviewing and approving documentation related to design controls, good manufacturing practices, medical device quality management, and corrective and preventive actions; and providing expertise in process validation, test method validation, statistical techniques, and root cause analysis.

Regulatory Affairs Pre-Market

Responsible for evaluating, interpreting and meeting all regulatory requirements for countries where Applied Medical is directly responsible for regulatory compliance and facilitating the design control process with expertise in biocompatibility, sterilization and product labeling.

Quality Control

Responsible for implementing and administering the company’s quality standards, processes and procedures; inspecting products and materials in accordance with engineering drawings, standard operating procedures (SOPs) and work instructions; documenting and maintaining inspection results; and assisting with external and internal on-site audits.

Regulatory Affairs Post-Market

Responsible for coordinating post-market surveillance, including facilitating complaint investigations; trending complaint data; managing recalls; participating in medical device reporting to the FDA and other regulatory bodies; and sending notifications to applicable distributors.

Quality Systems

Responsible for maintaining our quality system by keeping our procedures in line with standards and regulations; implementing new processes; participating in inspections and audits; and managing the corrective and preventive action (CAPA) process.

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Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, ancestry, national origin, religion, creed, age, mental or physical disability, sex, gender (including pregnancy), sexual orientation, gender identity or expression, genetic information, marital status, military or veteran status, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.