Specialist – Premarket Regulatory Affairs

Industry: Regulatory Affairs / QA / QC / QS

Company: Applied Medical

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 in a larger capacity than is possible in typical positions.

Position Description

Position Overview: 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.

Key Responsibilities:

• Premarket Submission Management: 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.
• Regulatory Strategy Development: 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. Coordinate with global team members on evolving regulatory requirements, standards, and guidelines in various markets, including Asia Pacific, Latin America, the European Union, and MENAT (Middle East, North Africa).
• Regulatory Compliance Monitoring: Monitor changes in regulatory landscape, including Food and Drug Administration (FDA) regulations and international standards, and assess their impact on ongoing and future projects. Proactively identify potential regulatory risks and provide recommendations for mitigation strategies.
• Cross-Functional Collaboration: Collaborate effectively with cross-functional teams, including Engineering, Quality and Clinical Development to gather necessary information and align regulatory activities with product development milestones. Act as a regulatory liaison to facilitate communication and understanding of regulatory requirements between project teams and Applied Medical’s global regulatory resources.

Performance Objectives:

Within your first 30 days:

• Complete all Applied Learning foundational courses with a passing grade of 95% or above, demonstrating rapid integration into company processes.
• Initiate meetings with key cross-functional team members, including Engineering, Quality, Clinical Development, and Planning to establish effective communication channels. Understand ongoing projects, product development timelines, and regulatory needs.
• Adhere to Applied Medical’s Quality Systems (QS), safety rules, and company policies.
• Provide support to creation and review of regulatory documentation for current projects.

Within 60 days:

• Actively participate in ongoing premarket regulatory projects. Contribute to the preparation of regulatory submissions and documentation, gaining hands-on experience in navigating regulatory pathways.
• Provide input into the development and refinement of regulatory strategies for current and upcoming medical device projects. Collaborate with team members to align regulatory activities with project milestones.
• Interact with global RA team members as necessary to support regulatory documentation requests and provide submittal assistance.
• Exhibit a strong technical understanding of the product lines and projects.

Within 90 days to 1 year:

• Function as primary regulatory support to one or more device product teams, assisting with regulatory strategies, planning and questions specific to projects for the devices.
• Consider multiple pathways to compliance and incorporate diverse perspectives when creating solutions, acting as a liaison to internal and external customers.
• Take ownership of premarket submission projects, overseeing the preparation, compilation, and submission process. Ensure all regulatory documentation meets the required standards and timelines.
• Collaborate with departments to ensure readiness for internal and external audits, as required.
• Demonstrate a strong understanding of Applied Medical Quality Management System and effectively troubleshoot challenges or obstacles that may affect project timelines.

Position 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

Preferred

The following skills and attributes are preferred:

• 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

If you are excited about making a significant impact, driving innovation, and contributing to a dynamic team, we encourage you to apply and embark on an exciting journey of engineering excellence at Applied Medical. Our unique business model empowers team members to have a substantial impact, unlike conventional roles.

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.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

Equal Opportunity Employer

Applied Medical is an Equal 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 status protected by federal, state or local laws in the locations where Applied Medical operates.