Associate Specialist- Post Market Regulatory Affairs

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. 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 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. Position Description

As an Associate Specialist in Post-market Regulatory Affairs, plays a crucial role in ensuring that our medical devices continue to meet regulatory requirements and maintain their safety and effectiveness after they have been introduced to the market. This role involves working closely with cross-functional teams within applied medical, including Quality Assurance, Research and Development, Clinical Affairs, and more. Areas of Responsibilities: Coordinate and support activities, with guidance and supervision, related to regulatory compliance in various countries. Provide analytical, operational and technical support to customers, regulatory agencies, suppliers, and internal teams. Support internal and external audit activities. Meet and exceed customer expectations. Understand and follow Applied Medical's Quality Systems per training. Customer Satisfaction Responsibilities: Document product complaints submitted by phone, email, and other methods. Make initial determinations of the reportability of product complaints based on the provided information. Follow up with internal and external partners to gather additional information about the product complaint events. Work with Complaint Processing and Complaint Engineering teams to provide information necessary for Adverse Event Reports and Complaint Root Cause Investigations. Maintaining knowledge of the major product lines sold by Applied Medical. Review and update standard operating procedures (SOPs) that are applicable to the Customer Satisfaction and Post-Market Regulatory Affairs role. Compliance Maintenance: Assist in managing regulatory activities related to post-market surveillance and complaint handling to ensure compliance with applicable regulations and standards. Adverse Event Reporting: Support the preparation and submission of adverse event reports to regulatory agencies within specified timeframes, ensuring accuracy and completeness of documentation. Complaint Handling: Review and assess customer complaints, identifying potential product issues that require investigation and reporting. Collaborate with internal departments to investigate complaints, determine root causes, and develop corrective and preventive actions (CAPAs). Documentation and Recordkeeping: Maintain organized and up-to-date regulatory files, ensuring that all required documentation is complete, accurate, and accessible for audits and inspections. Assist in the preparation of regulatory submissions, including annual reports, updates to product labeling, and other post-market documentation. Regulatory Intelligence: Stay informed about relevant regulatory changes, guidance documents, and industry trends related to post-market activities. Translate regulatory requirements into actionable steps for the company, ensuring continued compliance and improved product quality. Position Requirements

Knowledge of existing and emerging regulations, standards, or guidance documents. Ability to work independently and as part of a team. Committed to continuous improvements in quality. Analytical, meticulous, and detail oriented. Assertive and not afraid to ask questions. Effective oral and written communication and presentation skills. Friendly, good attitude, and customer service oriented. Ability to multi-task, organize, and prioritize. Preferred

Bachelors degree in Engineering, Physical or Biological Sciences, Regulatory, other technical disciplines, or equivalent. Training in Quality Systems, including Quality Systems Regulations (QSRs) and Good Manufacturing Practices (GMPs) for medical devices and International Organization for Standardization (ISO). 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. 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. #J-18808-Ljbffr