Associate Labeling Specialist – Regulatory Affairs

Applied Medical · Rancho Santa Margarita, CA

$71k – $80k/yr

<img style="display: block; margin-left: auto; margin-right: auto;" src="https://appliedmedical.icims.com/icims2/servlet/icims2?module=AppInert&action=download&id=66&hashed=-1305937254" alt="Applied-Medical-Logo-w-Tag_H_Teal_cropped" />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. Position Description The Associate Labeling Specialist supports regulatory labeling strategy and quality system compliance within the Regulatory Affairs Labeling team at Applied Medical. This role contributes to the development, review, and maintenance of product labeling across global markets, ensuring alignment with applicable regulations and standards in all regions where Applied Medical products are distributed.

The Associate Labeling Specialist works cross-functionally to support labeling projects from design input through final approval, making this an ideal opportunity for professionals with a background in regulatory affairs, quality assurance, or technical writing in the medical device industry. Candidates with experience in labeling compliance, Quality System Regulations (QSRs), or regulatory documentation will find this role a strong fit. Key Responsibilities<ul><li>Lead the planning, coordination, and tracking of labeling projects across multiple departments, ensuring timelines and compliance requirements are met.</li><li>Review and approve product labeling to verify accuracy, completeness, and alignment with applicable global regulations and standards.</li><li>Support the upkeep and continuous improvement of the labeling manual, including design inputs, specifications, and final labeling processes.</li><li>Collaborate with cross-functional teams including Engineering, Quality, and Operations to maintain effective technical communication throughout the labeling lifecycle.</li><li>Monitor global labeling regulations, standards, and guidance documents to ensure Applied Medical's Quality System remains current and compliant.</li><li>Support related quality subsystems, including non-conformances and corrective and preventive actions (CAPA), as they relate to labeling activities.</li><li>Apply labeling software and technical tools to manage translation workflows and documentation requirements across international markets.</li></ul>Success in This Role Looks Like<ul><li>Building a strong foundational understanding of Applied Medical's mission, quality systems, and product lines within the first 30 days by engaging with team resources, Applied Learning courses, and cross-functional discussions.</li><li>Taking on projects that require low to moderate guidance within the first 60 days, demonstrating a clear technical understanding of relevant product lines and contributing meaningfully to team meetings and agendas.</li><li>Acting as a liaison to internal and external customers within the first year, coordinating responses to questions and representing the Labeling team in internal and external audits.</li><li>Identifying and proposing process improvements to labeling systems, workflows, and quality practices on an ongoing basis.</li><li>Leading moderate to complex labeling projects with minimal direction, while proactively troubleshooting obstacles that affect project timelines.</li><li>Providing expertise and guidance to team members across the organization, contributing to a broader culture of quality and continuous improvement.</li></ul> Position Requirements This position requires the following skills and attributes:<ul><li>Bachelor's degree in Engineering, Physical or Biological Sciences, Regulatory Affairs, or an equivalent technical field of study.</li><li>Demonstrated ability to review, interpret, and apply global labeling regulations, standards, and guidance documents in a medical device or regulated industry environment.</li><li>Strong technical writing skills with experience producing or reviewing regulatory documentation.</li><li>Proven ability to manage multiple projects and priorities simultaneously with attention to detail and consistent follow-through.</li><li>Effective oral and written communication skills, including the ability to present complex topics clearly to stakeholders at varying levels.</li><li>Collaborative mindset with the ability to work independently and as part of a cross-functional team.</li><li>Committed to quality, continuous improvement, and exceeding customer expectations.</li><li>Familiarity with Quality Systems Regulations (QSRs), Good Manufacturing Practices (GMPs), and ISO standards for medical devices.</li></ul> Preferred The following skills and attributes are preferred:<ul><li>At least one year of experience in Regulatory Affairs or Quality Assurance in the medical device industry.</li><li>Experience working with labeling software or regulatory documentation management tools.</li><li>Exposure to labeling translation workflows and international regulatory submissions.</li><li>Training or coursework in regulatory affairs, quality systems, or a related compliance discipline.</li></ul> Benefits <ul style="margin-top: 0in;"><li>Competitive compensation range: $71000 - $80000 / year (California).</li><li>Comprehensive benefits package.</li><li>Training and mentorship opportunities.</li><li>On-campus wellness activities.</li><li>Education reimbursement program.</li><li>401(k) program with discretionary employer match.</li><li>Generous vacation accrual and paid holiday schedule.</li></ul>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 EmployerApplied Medical

Originally posted by Applied Medical. View original posting

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