Applied Medical is a rapidly growing new generation medical device company with a proven business model and commitment to innovation. Developing and manufacturing advanced surgical technologies for over 30 years, Applied Medical has earned a strong reputation in healthcare as being dedicated to delivering the highest quality products and meeting customer needs.

The Regulatory Affairs team plays a critical role in all phases of the device lifecycle, including design and configuration, development, approval, and post-market surveillance. The team applies creativity and critical thinking to market implementation and regulatory submission strategies which enables Applied Medical’s devices to make a meaningful, positive difference in more than 80 countries.

Pursuing a positive, growth-driven environment, leaders at Applied Medical prioritize team member development. Management on the Regulatory Affairs team identify and create opportunities for team members to professionally grow and cultivate.

We kindly ask that you submit a cover letter explaining your career interests in addition to your resume and application. Depending on your level of experience, this posting is for a Specialist or Senior Specialist role.

As Premarket Regulatory Affairs (Senior) Specialist, you will be responsible for being a self-starter and working in a collaborative environment to perform the duties listed below.

• Understand the design, manufacturing process and clinical application of one of our medical devices
• Seek to understand multiple pathways to compliance and incorporate all perspectives in creating solutions and decision making
• Monitor the regulatory environment, including relevant domestic and international standards, regulations, and guidance documents
• Manage regulatory submissions and communicate with regulatory authorities
• Collaborate with Engineering, Clinical Development and other departments in the design and development process of our medical devices and ensure regulatory requirements are met in the markets where devices are distributed
• Contribute to regulatory strategy planning and change management in US and European Union markets
• Review and approve design history and risk management file documentation (e.g., design inputs and outputs, hazard analyses, clinical evaluation reports) and product labeling
• Review and approve other quality records such as those associated with Non-Conforming Investigation Reports, Temporary Deviation Orders, and Corrective and Preventative Actions
• Participate in audits and inspections by regulatory agencies
• Mentor team members throughout the organization through subject matter expertise and experience
• Propose, initiate and drive business process improvement projects

This position requires the following skills and attributes:

• Minimum 2 years (Specialist) or 5 years (Senior Specialist) of experience in Regulatory Affairs or Quality Assurance in the medical device industry
• Minimum 1 year of active experience applying design controls
• Experience in reviewing and approving technical documentation
• Technical background in engineering, or biological or physical sciences
• Experience effectively managing projects and developing advanced organizational skills
• Ability to multitask and prioritize projects that align with departmental and organizational objectives
• Working knowledge of domestic and international regulations, standards and guidance documents
• Strong writing, verbal and interpersonal communication skills
• Ability to work independently and as part of a team
• Assertive and not afraid to ask questions
• Strategic-minded, analytical and detail-oriented

As a healthcare company, it is of the utmost importance to keep our teams safe and healthy in this ever-changing COVID-19 environment. We require all new team members to be fully vaccinated (including booster shots, if eligible) upon their start date at Applied Medical (legitimate accommodation requests will be considered). Our current team members have also made this commitment to being vaccinated and receiving the booster shot to help protect each other, our families, our customers, and our visitors, as we work together to help end the pandemic. Eligibility details to receive the COVID-19 booster shot are provided on the CDC website here.

The following skills and attributes are preferred:

• Training in quality systems including QSR, ISO and CE marking, usability, and human factors
• Experience with mechanical and electrical medical devices 

• Training and mentorship with ongoing learning and development courses
• On-campus wellness activities
• Comprehensive medical and dental and vision coverage
• Education reimbursement program
• 401(k) program with discretionary employer match
• Generous vacation accrual and paid holiday schedule

Equal Opportunity Employer

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.