Job Information
Actalent Post Market Surveillance Specialist in New Prague, Minnesota
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Description:
The Post Market Surveillance Specialist is integral in managing customer complaints through detailed evaluation and investigation, ensuring compliance with regulatory standards through thorough analysis and reporting. They collaborate with internal stakeholders and project teams to develop and execute regulatory strategies, contributing to product safety, efficacy, and regulatory approval processes. Responsibilities also include supporting quality and regulatory system improvements, maintaining documentation, and participating in audits to enhance organizational compliance and efficiency. The Post Market Surveillance Specialist is part of a team that values innovation and quality in a dynamic environment.
Intake, evaluate, and process customer complaints, ensuring that each investigation is comprehensive, accurate, and detailed.
Participate in root cause investigations and product analysis to address the underlying issues of customer complaints, contributing to thorough and effective resolutions.
Conduct trend reporting to identify significant findings and escalate these to Quality Engineering (QE) or relevant investigating stakeholders as necessary, ensuring prompt and appropriate actions.
Review and collaborate with stakeholders to file appropriate medical device reports with regulatory agencies, ensuring compliance with regulatory standards.
Maintain and generate post-market surveillance reports to adhere to regulatory requirements, playing a key role in ongoing product safety and efficacy monitoring.
Support the handling of complaints during internal and external audits, demonstrating the organization's commitment to quality and regulatory compliance.
Provide support in the continuous improvement of the quality system for processing complaints, meeting FDA, ISO, and international regulatory requirements, thereby enhancing the organization's quality standards.
Work closely with project teams to conduct regulatory evaluations, develop strategies, and execute regulatory plans, ensuring that new product developments and modifications meet all regulatory criteria.
Collaborate with the Head of Regulatory Affairs and Quality Assurance (RA/QA) to interpret regulatory requirements and work with stakeholders to define specific activities required for compliance and product approvals.
Assist in the preparation of submissions for product clearances/approvals and renewals and in the maintenance of regulatory documentation for international registrations, ensuring a smooth and compliant market entry and presence.
Engage in Regulatory Intelligence activities to stay informed on evolving regulatory trends, enabling the organization to adapt and implement necessary actions proactively.
Support process improvement initiatives for quality and regulatory systems, enhance compliance and operational efficiency, and contribute to the organization's overall performance in quality and regulatory affairs.
Support and correspond with clinical study representatives when performed.
Additional Skills & Qualifications:
High school diploma or equivalent; Associates or Bachelors preferred.
Comprehensive understanding of key regulatory standards and directives, including European Union Medical Device Regulation (MDR), ISO 13485, IEC 60601-1.
Experience supporting regulatory strategies, documentation preparation, and compliance activities, with a willingness to learn from senior leadership and contribute to team efforts.
Exposure to FDA inspections, ISO 13485 audits, and regulatory communications
Basic understanding of product development, design controls, and the ability to understand technical specifications.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.