Specialist - Premarket Regulatory Affairs

Applied Medical•Rancho Santa Margarita, CA

6d•Onsite

About The Position

Applied Medical is a medical device company that develops and manufactures surgical technologies. The Specialist in Premarket Regulatory Affairs helps ensure regulatory compliance during early product development. The role is 100% onsite and collaborates with cross-functional teams on projects and on maintaining and improving Quality Systems. The specialist coordinates the preparation, compilation, and submission of premarket regulatory documentation, including 510(k) submissions, EU Medical Device Regulation filings, and other international filings. The role contributes to regulatory strategies for new products and product changes, coordinates with global teams on regulatory requirements across markets, monitors regulatory developments and assesses their impact, identifies regulatory risks, and recommends mitigation strategies. The specialist also works with Engineering, Quality, and Clinical Development to align regulatory activities with product development milestones and acts as a regulatory liaison between project teams and global regulatory resources.

Requirements

At least two years of experience in Regulatory Affairs or Quality Assurance in the medical device industry.
At least one year of active experience applying design controls.
Experience reviewing and approving technical documentation.
Technical background in engineering, biological sciences, or physical sciences.
Experience managing projects and advanced organizational skills.
Ability to multitask and prioritize projects according to departmental and organizational objectives.
Working knowledge of domestic and international regulations, standards, and guidance documents.
Strong writing, verbal, and interpersonal communication skills.
Ability to work independently and as part of a team.
Assertiveness and willingness to ask questions.
Strategic mindset, analytical ability, and attention to detail.

Nice To Haves

Training in Quality Systems, including Quality Systems Regulations (QSRs), Good Manufacturing Practices (GMPs) for medical devices, and ISO standards.
Experience with mechanical and electrical medical devices.
Proficiency in speaking and writing Japanese or Korean.

Responsibilities

Coordinate and manage preparation, compilation, and submission of premarket regulatory documentation, including 510(k), EU Medical Device Regulation, and other international filings.
Contribute to regulatory strategies for new medical device products and support regulatory planning for product change and improvement projects.
Coordinate with global team members regarding evolving regulatory requirements, standards, and guidelines in Asia Pacific, Latin America, the European Union, and MENAT.
Monitor changes in FDA regulations, international regulations, and standards, and assess their impact on ongoing and future projects.
Identify potential regulatory risks and recommend mitigation strategies.
Collaborate with Engineering, Quality, and Clinical Development to gather information and align regulatory activities with product development milestones.
Act as a regulatory liaison to facilitate understanding and communication of regulatory requirements between project teams and global regulatory resources.
Participate in projects to maintain and improve Quality Systems.