Associate Specialist – Premarket Regulatory Affairs

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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

Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work full-time on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role.  

AREAS OF RESPONSIBILITY

The associate specialist is responsible for contributing 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. The team member must be capable of working within a team environment, striving to meet customer expectations, and committing to continuous improvements in quality.

REGULATORY AND QUALITY PROJECT MANAGEMENT

Contribute to regulatory submissions, and projects for maintaining and improving the Quality System. 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.

COMMUNICATION

Collaborate with Engineering, Clinical Development, and global regulatory teams to meet regulatory requirements in markets where devices are distributed. Seek guidance and feedback from higher-level authorities, such as the Specialist, Senior Specialist, Manager, Director, or Vice President of Regulatory Affairs, and other teams.

PROBLEM SOLVING

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. Consider multiple pathways to compliance and incorporate diverse perspectives when creating solutions.

PERFORMANCE OBJECTIVES

Within your first 6 months, you will be responsible for learning about our company, contributing to various projects and leading project management initiatives.

During your first 30 days, you will:

• Learn about Applied Medical’s mission and vision and take part in a variety of Applied Learning foundational courses.
• Discuss your goals and expectations with your team leader(s) and read and review all relevant team resources and materials.
• Immerse yourself in team meetings and discussions.
• 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, you will:

• Participate in product configuration management team meetings and contribute to configuration implementation planning for specific devices.
• Exhibit a strong technical understanding of the product line(s) and/or projects
• Support team meetings and agendas.
• Take on one or more projects that require low to moderate guidance.

Within 90 days to 1 year, you will:

• Consider multiple pathways to compliance and incorporate diverse perspectives when creating solutions.
• Coordinate and respond to questions, acting as a liaison to internal and external customers.
• Review Clinical Evaluations and Post-Market Follow-Up documentation as assigned.
• Participate in internal and external audits, as required.
• Propose, initiate, and contribute to business process improvement projects.
• Provide advice and expertise to other team members throughout the organization.
• Lead moderate to complex projects with minimal guidance or direction.
• Demonstrate a strong understanding of Applied Medical Quality Management System and effectively troubleshoot challenges or obstacles that may affect project timelines.

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
• 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 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.

Salary : $70,000 - $80,000