Associate Labeling Specialist – Regulatory Affairs

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field.  Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

As an Associate Labeling Specialist, you will work onsite at our global headquarters within our Regulatory Affairs Labeling team. You will play a key role in supporting regulatory labeling strategies and contributing to projects aimed at maintaining and enhancing the Quality System. You will ensure that Applied Medical’s Quality System complies with applicable standards and regulations in the regions where its products are distributed. The ideal candidate thrives in a collaborative team environment, is dedicated to exceeding customer expectations, and is committed to continuous improvement in quality.

Key Responsibilities:

• Project Management: Gain expertise in labeling components, including design inputs, specifications, and final labeling processes. Support the upkeep and continuous improvement of the labeling manual. Lead the planning, coordination, and tracking of labeling projects across multiple departments. Support and understand related quality subsystems, including non-conformances and corrective/preventative actions (CAPA).
• Documentation: Review and approve product labeling to ensure accuracy and compliance. Stay informed of global labeling regulations, standards, and guidance documents.
• Communication: Collaborate with cross-functional teams and maintain effective technical communication. Present complex topics clearly and concisely to stakeholders and leadership.
• Problem Solving: Stay informed of global labeling regulations, standards, and guidance documents. Conduct research and stay current with subject matter relevant to labeling. Acquire knowledge of the labeling translation workflow. Work with labeling software and related technical tools.

Performance Objectives:

Within your first 6 months, you will be responsible for learning about our company, contributing to various projects and leading project management initiatives.

Within your first 30 days:

• Learn about Applied Medical’s mission and vision and take part in a variety of Applied Learning foundational courses.
• Discuss your goals and expectations with your team leader(s) and read and review all relevant team resources and materials.
• Immerse yourself in team meetings and discussions.
• Adhere to Applied Medical's Quality Systems (QS), safety rules, and company policies.
• Provide support to creation and review of regulatory documentation for current projects

Within 60 days:

• Exhibit a strong technical understanding of the product line(s) and/or projects
• Support team meetings and agendas.
• Take on one or more projects that require low to moderate guidance.

Within 90 days to one year:

• Consider multiple pathways to compliance and incorporate diverse perspectives when creating solutions.
• Coordinate and respond to questions, acting as a liaison to internal and external customers.
• Participate and represent labeling in internal and external audits.
• Identify and propose improvements to labeling processes, systems, and overall quality.
• Provide advice and expertise to other team members throughout the organization.
• Lead moderate to complex projects with minimal guidance or direction.
• Demonstrate a strong understanding of Applied Medical Quality Management System and effectively troubleshoot challenges or obstacles that may affect project timelines.

• Proficient in interpreting existing and emerging regulations, standards, or guidance documents.
• Highly motivated, self-starter, able to work independently and as part of a team.
• Strong analytical, detail-oriented, proactive mindset, not afraid to ask questions.
• Effective oral and written communication and presentation skills.
• Friendly, positive attitude, committed to excellent customer service.
• Exemplary time and resource management skills, able to multitask, organize, and prioritize.
• Strong technical writing skills.
• Committed to quality and continuous improvement, strives to meet, or exceed customer expectations.

• At least one year of experience in Regulatory Affairs or Quality Assurance in the medical device industry.
• Bachelor's degree in Engineering, Physical or Biological Sciences, Regulatory, other technical disciplines, or an equivalent field of study.
• Training in Quality Systems, including Quality Systems Regulations (QSRs) and Good Manufacturing Practices (GMPs) for medical devices, and International Organization for Standardization (ISO) standards.

If you are excited about making a significant impact, driving innovation, and contributing to a dynamic team, we encourage you to apply and embark on an exciting journey of excellence at Applied Medical. Our unique business model empowers our team members to have a substantial impact, unlike conventional roles. 

• Competitive compensation range: $70000 - $80000 / year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

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.

Salary : $70,000 - $80,000