Associate Specialist – Premarket Regulatory Affairs (Global)

Applied Medical•Rancho Santa Margarita, CA

11d•Onsite

About The Position

Join Applied Medical as an Associate Specialist in Premarket Regulatory Affairs and help shape the future of medical innovation across our global markets. You will be 100% on site, collaborating closely with cross-functional teams to support product development while ensuring alignment with regulatory standards. Your contributions will be key to maintaining and enhancing our Quality Systems, driving compliance from the earliest stages. This is your opportunity to make a meaningful impact on healthcare by helping bring safe, effective medical devices to market.

Requirements

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

Nice To Haves

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
Familiarity with international regulations and experience with activities for the registration of medical devices in various global regions (such as Asia/Pacific, Latin America, Middle East).
Proficiency in speaking and writing in Japanese or Korean is preferred

Responsibilities

Contribute to regulatory strategy development and regulatory submissions for global markets.
Support projects that maintain, improve, and ensure compliance of the Quality Management System.
Participate in regulatory change management activities across Asia Pacific, Latin America, the European Union, and MENAT regions.
Research, monitor, and analyze global regulations, standards, and guidance documents to support regulatory intelligence efforts.
Collaborate with global regulatory teams to support submissions, strategic initiatives, and process improvements.
Assist with regulatory decision-making and cross-functional discussions related to domestic and international regulations.
Partner with Engineering, Clinical Development, and global teams to ensure regulatory requirements are met in markets where products are distributed.
Facilitate communication of project updates, regulatory requirements, and process changes between global and local teams.
Seek and incorporate guidance from regulatory leadership and subject matter experts.
Generate, review, and approve regulatory documentation, including regulatory assessments, declarations of conformity, technical file summaries, and product labeling.
Monitor regulatory changes and implement procedural updates and training to maintain compliance.
Evaluate multiple compliance pathways and apply critical thinking to develop effective regulatory solutions.
Contribute effectively within a team environment while supporting customer expectations and continuous quality improvement initiatives.