Applied Medical · 4 months ago
Associate Specialist – Premarket Regulatory Affairs
Rancho Santa Margarita, CA
Full-time
Onsite
Entry Level
$70K/yr - $80K/yr
1+ years expApplied Medical is a new-generation medical device company committed to innovation and excellence in healthcare. The Associate Specialist in Premarket Regulatory Affairs will support product development by ensuring compliance with regulatory standards and enhancing Quality Systems. This role involves collaboration with cross-functional teams and contributing to regulatory strategy and submissions for medical devices.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Contribute to regulatory strategy and submission, participating in projects to maintain and improve the Quality Systems and ensuring that Applied Medical's Quality Systems conforms to standards and regulations in regions where Applied Medical products are distributed
Contribute to regulatory submissions, and projects for maintaining and improving the Quality System
Engage in regulatory strategy planning and change management for various markets, including Asia Pacific, Latin America, the European Union, and MENAT (Middle East North Africa)
Represent Regulatory Affairs in decision-making and interdepartmental meetings related to domestic and international regulations
Collaborate with Engineering, Clinical Development, and global regulatory teams to meet regulatory requirements in markets where devices are distributed
Seek guidance and feedback from higher-level authorities, such as the Specialist, Senior Specialist, Manager, Director, or Vice President of Regulatory Affairs, and other teams
Generate, review, and approve regulatory documentation, including assessments of regulatory actions, declarations of conformity, technical file summaries, and product labeling
Monitor the regulatory environment, keep current on relevant domestic and international standards, regulations, and guidance documents, and implement procedural updates and training to ensure conformance
Consider multiple pathways to compliance and incorporate diverse perspectives when creating solutions
Qualification
Required
At least one year of experience in Regulatory Affairs or Quality Assurance in the medical device industry
Proficient in interpreting regulations and standards
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
Preferred
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
Proficiency in speaking and writing in Japanese or Korean is preferred
Benefits
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.
Company
Applied Medical
As a new generation medical device company, Applied Medical is focused on meeting three fundamental healthcare needs: enhanced clinical outcomes, cost containment and unrestricted choice.
Founded in 1987Rancho Santa Margarita, California, USA
5001-10000 employees
H1B Sponsorship
Applied Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (32)
2023 (23)
2022 (34)
2021 (18)
2020 (12)
Funding
Current Stage
Late StageLeadership Team
Samir Tall
Senior VP and CFO
Hany Louis
Chief Accounting Officer
Recent News
Google Patent
2025-04-03
Google Patent
2025-04-03
Company data provided by crunchbase