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 to a larger capacity than is possible in typical positions.
Position Description
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.
Key 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.
What Success Looks Like in This Role
- Regulatory submissions are completed accurately, on time, and in compliance with applicable global requirements.
- Quality System projects are effectively supported and contribute to ongoing compliance and process improvement.
- Regulatory changes and emerging requirements are proactively identified, assessed, and communicated to stakeholders.
- Strong partnerships are built across Engineering, Clinical Development, Quality, and global Regulatory Affairs teams.
- Regulatory documentation is thorough, compliant, and maintained with a high level of quality and attention to detail.
Position Requirements
This position requires the following skills and attributes:
- 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
The following skills and attributes are 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
- 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
Benefits
- Competitive compensation range: $70000 - $80000 / year (California).
- 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.
Please note that the compensation range may be based on factors such as relevant education, qualifications, experience. The compensation range may be adjusted in the future, and special discretionary bonus or incentive compensation plans may apply.
Our total reward package reflects our commitment to team member growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.
Equal Opportunity Employer
Applied Medical is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other basis protected by federal, state or local laws in the locations where Applied Medical operates.