Regulatory Affairs Job at Applied Medical, California | Biological Sciences | Apply Now
Stepping into the medical device industry requires precision, strategic thinking, and a keen eye for compliance. If you are exploring the market for a dynamic Regulatory Affairs Job, this Associate Labeling Specialist position at Applied Medical is a standout opportunity. Located in Rancho Santa Margarita, this role is a highly competitive Job in California that offers a clear trajectory for professionals transitioning from technical writing, quality assurance, or broader Biology Jobs into specialized regulatory pathways.
- Job Position: Associate Labeling Specialist – Regulatory Affairs
- Location: Rancho Santa Margarita, California
- Category: Regulatory Affairs / QA / QC / QS
- Job ID: 14677
About the Company
For over 35 years, Applied Medical has been a driving force in advanced surgical technologies. They operate on a unique, vertically integrated business model that allows team members to have a much larger impact than in typical corporate structures. Joining their Rancho Santa Margarita campus means entering an environment fueled by rapid growth, a commitment to innovation, and a strong culture of continuous improvement.
Regulatory Affairs Job – Key Responsibilities
As an Associate Labeling Specialist, you are the gatekeeper of product information. Your primary mission is to ensure that every piece of medical device labeling aligns with stringent global regulations before it reaches the hands of a surgeon or patient.
- Project Leadership: Plan, coordinate, and track labeling projects from design input through final approval.
- Global Compliance: Review product labeling for accuracy and alignment with international regulations, standards, and guidance documents.
- Cross-Functional Collaboration: Act as the central communication hub between Engineering, Quality, and Operations to ensure technical accuracy.
- Quality Systems Stewardship: Support quality subsystems, including Non-Conformances and CAPA (Corrective and Preventive Actions), as they relate to labeling.
- Translation Management: Utilize specialized software to manage complex translation workflows for international markets.
Success in Year One: Within the first 30 to 60 days, you will transition from learning their Quality Systems to taking on projects with moderate guidance. By the end of your first year, you will be acting as a key liaison during internal and external audits and leading complex projects with minimal direction.
Candidate Profile: Qualifications & Skills For Regulatory Affairs Job
This Regulatory Affairs Job bridges the gap between scientific understanding and legal compliance. It is an ideal progression for individuals looking to leverage their scientific background in the corporate sector.
- Educational Foundation: A Bachelor’s degree in Engineering, Biological Sciences, Regulatory Affairs, or an equivalent technical field. This makes it a prime target for those pivoting from traditional Biology Jobs.
- Technical Writing: Strong ability to produce, review, and interpret complex regulatory documentation.
- Regulatory Knowledge: Familiarity with FDA Quality System Regulations (QSRs), Good Manufacturing Practices (GMPs), and ISO standards (such as ISO 13485) is essential.
- Preferred Experience: At least one year of experience in a medical device QA/RA environment, exposure to translation workflows, or coursework in a related compliance discipline will give you a significant competitive edge.
Compensation & Total Rewards
Applied Medical offers a robust total rewards package designed to support well-being and professional development for this Job in California.
- Target Salary Range: $71,000 – $80,000 per year (plus potential bonus and incentive compensation plans).
- Retirement: 401(k) program with a discretionary employer match.
- Time Off: Generous vacation accrual and a paid holiday schedule.
- Professional Growth: Education reimbursement program, ongoing training, and mentorship opportunities.
- Wellness: Comprehensive benefits package alongside on-campus wellness activities.
In summary, the Associate Labeling Specialist position is a definitive Regulatory Affairs Job for professionals ready to make a tangible impact in the medical device sector. By securing this competitive Job in California, you are joining a vertically integrated company that genuinely values innovation, quality, and cross-functional collaboration. For candidates looking to transition away from traditional Biology Jobs and step into a highly specialized compliance pathway, Applied Medical offers the perfect foundation to build a long-lasting and rewarding regulatory career.
