Regulatory Specialist

People Purpose: Beyond Competitive
It is no longer ok to just be competitive regarding how we treat our people in everything we do. Our leadership team believes wholeheartedly we need to be beyond competitive and cultivate a culture of proud, driven employees who are passionate about the work they do and where they do it. Our leadership strives to unleash unsurpassed potential in every team and individual employed and owns making that happen. Sincere, Simple, Smart.
What makes us Beyond Competitive:

• Discretionary Time Off
• Employee bonus plan
• Flexible hybrid/remote work options
• Full pay maternity, paternity, parental, short-term disability leaves
• Employee driven recognition program
• Access to hundreds of training opportunities
• Company paid educational assistance
• Well-being on demand
• Perks at Work
• Competitive health and welfare plans -HSA company contribution
• 401(k) company match
• Great culture and people!

The Opportunity:
The Regulatory 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 Regulatory Specialist is part of a team that values innovation and quality in a dynamic environment. This is a flexible hybrid position based in New Prague, MN.
Job Outcomes You Must Get:

• 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 andrenewals 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 Electromed clinical study representatives when performed.

Job Outcomes Requirements:

• 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, and others relevant to the Electromed QMS.
• 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.

Be You.

Our people celebrate diverse individuals, backgrounds, and thinking. As an equal opportunity

employer this is the absolute most important belief in cultivating our

culture and growth together.

Core Values

Unwavering passion for Patients. Make it happen. Encourage innovation and creativity.

Embrace change. Always do what's right. Listen, learn, and deliver.

Electromed develops, manufactures, and markets innovative airway clearance devices that help

people around the world breathe better, stay healthier, and lead active and fulfilling lives.

Making Life’s important moments possible-one breath at a time.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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