Specialist – Premarket Regulatory Affairs

Job Type: Location Type: Not Specified

 

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

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.

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

• 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 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.