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.
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.
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“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
“To have a career that has provided me with so much learning and knowledge, has offered many great opportunities to grow and develop, and has allowed me to contribute to numerous accomplishments is beyond my expectations. Being able to experience all of that and witness a small company grow so large and become so successful has made this a very rewarding career.”
Patti C. - Team Member Since 2002
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.
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.
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.
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.
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.
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.
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.
Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.
