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Regulatory Affairs Specialist

2 months ago

Rancho Santa Margarita California, United States Applied Medical Full time
About the Role

We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at Applied Medical. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with regulatory requirements and maintaining the highest standards of quality in our products.

Key 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.
  • 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.
  • 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.
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.
Preferred Qualifications
  • 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.
What We Offer
  • Competitive compensation range: $80,000/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 vacation schedule.