Associate Specialist- Post Market Regulatory Affairs - Applied Medical

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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 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

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 leaders and read and review all relevant team resources and materials
• Immerse yourself in team meetings and discussions

Within 60 days, you will:

• Exhibit a strong technical understanding of the product lines and 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:

• Develop interpersonal connections and relationships with others to effectively accomplish project objectives and deliverables
• Lead moderate to complex projects with minimal guidance or direction
• Demonstrate a strong understanding of Applied Medical’s Quality Management System (QMS) and effectively troubleshoot challenges or obstacles that may affect project timelines
• Handle a variety of projects on your own

Inside This Business Group

 

The Post-market Regulatory Affairs team member is detail-oriented, has good organizational skills, possess a basic understanding of medical device regulations, and be willing to learn and adapt as regulations evolve. This role serves as a crucial part of the regulatory team and contributes to ensuring that medical devices meet the necessary requirements for market approval and patient safety.

Position Requirements:

This position requires the following skills and attributes:

• 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:

The following skills and attributes are preferred:

• Bachelor’s 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:

The base compensation range for this role is $68000 - $80000 / year for the position in California. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries in California based on the date of this job posting. Your recruiter can share more about the specific salary range compensation package during your hiring process. 

 

Please understand that the compensation range may be modified in the future. Each amount of pay is considered to be wages or compensation once such amount is earned and determinable. The amount and availability of any bonus, commission, benefit or any other form of compensation may be modified at the Company’s sole discretion, consistent with the law.

 

The total compensation package for this position may also include [bonuses and/or other applicable incentive compensation plans]. 

 

Our total reward package also includes the following:

• Training and mentorship with ongoing learning and development courses
• On-campus wellness activities
• Comprehensive medical and dental and vision coverage
• Education reimbursement program
• 401(k) program with discretionary employer match
• Generous vacation accrual and paid holiday schedule

All compensation and benefits are subject to the requirements and restrictions set forth in the applicable plan documents and any written agreements between the parties.

 

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.