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Specialist - Premarket Regulatory Affairs
Applied Medical Distribution - Rancho Santa Margarita, CA
posted 5 days ago
About the position
Join Applied Medical and play a crucial role in revolutionizing medical devices. As a Specialist in Premarket Regulatory Affairs, you will play a pivotal role in ensuring compliance with regulatory requirements during the early stages of product development. You'll be 100% onsite collaborating with cross-functional teams participating in projects to maintain and improve the Quality Systems. It's your chance to make an enduring impact on the future of healthcare.
Responsibilities
- Coordinate and manage the preparation, compilation, and submission of premarket regulatory documentation, including 510K submissions, European Union (EU) Medical Device Regulation, and other international filings ensuring accuracy, completeness, and adherence to regulatory requirements.
- Contribute to the development and implementation of regulatory strategies for new medical device products. Support product teams with regulatory planning for various product change and improvement projects.
- Monitor changes in regulatory landscape, including Food and Drug Administration (FDA) regulations and international standards, and assess their impact on ongoing and future projects.
- Collaborate effectively with cross-functional teams, including Engineering, Quality and Clinical Development to gather necessary information and align regulatory activities with product development milestones.
Requirements
- Minimum two years of experience in Regulatory Affairs or Quality Assurance in the medical device industry
- Minimum one year of active experience applying design controls
- Experience in reviewing and approving technical documentation
- Technical background in engineering, biological, or physical sciences
- Experience effectively managing projects and developing advanced organizational skills
- Ability to multitask and prioritize projects that align with 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
- Assertive and not afraid to ask questions
- Strategic-minded, analytical and detail-oriented
Nice-to-haves
- Training in Quality Systems, including Quality Systems Regulations (QSRs) and Good Manufacturing Practices (GMPs) for medical devices, and International Organization for Standardization (ISO) standards
- Experience with mechanical and electrical medical devices
- Proficiency in speaking and writing in Japanese or Korean is preferred
Benefits
- Competitive compensation range: $80000 - $100000 / 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
