TRICARDIA
Senior Regulatory Specialist
Onsite: Maple Grove, MN Medical Device - Interventional Cardiology - Structural Heart
Im working with a fast growing structural heart medical device company to help them hire a Senior Regulatory Specialist in Maple Grove, MN.
This role will take ownership of global regulatory submissions and technical documentation to support IDE, PMA, and EU MDR filings, working closely with R&D, Quality & Clinical Affairs. Its a great opportunity for someone who enjoys both the detail of regulatory work and being part of a fast-paced, innovative environment.
Key Responsibilities Review and finalize engineering test reports and technical deliverables to support FDA, EU MDR, and other global submissions. Prepare and support U.S. and international regulatory submissions (IDE, PMA, 510(k), EU MDR, Health Canada, Japan Shonin, etc.). Collaborate with engineering and subject matter experts to address regulatory questions and respond to agency inquiries. Maintain current knowledge of global medical device regulations and ensure compliance. Review labeling, documentation changes, and marketing materials for regulatory accuracy. Assess product and manufacturing changes for regulatory impact and manage required documentation or approvals.
Qualifications Bachelors degree in Engineering or related field. Minimum 3 years of regulatory affairs experience in the medical device industry. Experience with FDA submissions (IDE, PMA, 510(k)) and international pathways (EU MDR, Health Canada, Japan Shonin) preferred. Strong writing, editing, and analytical skills with attention to detail. Proficiency in Microsoft Office and regulatory document tools. Highly organized with the ability to manage multiple projects. Willingness to travel up to 10%.
Onsite: Maple Grove, MN Medical Device - Interventional Cardiology - Structural Heart
Im working with a fast growing structural heart medical device company to help them hire a Senior Regulatory Specialist in Maple Grove, MN.
This role will take ownership of global regulatory submissions and technical documentation to support IDE, PMA, and EU MDR filings, working closely with R&D, Quality & Clinical Affairs. Its a great opportunity for someone who enjoys both the detail of regulatory work and being part of a fast-paced, innovative environment.
Key Responsibilities Review and finalize engineering test reports and technical deliverables to support FDA, EU MDR, and other global submissions. Prepare and support U.S. and international regulatory submissions (IDE, PMA, 510(k), EU MDR, Health Canada, Japan Shonin, etc.). Collaborate with engineering and subject matter experts to address regulatory questions and respond to agency inquiries. Maintain current knowledge of global medical device regulations and ensure compliance. Review labeling, documentation changes, and marketing materials for regulatory accuracy. Assess product and manufacturing changes for regulatory impact and manage required documentation or approvals.
Qualifications Bachelors degree in Engineering or related field. Minimum 3 years of regulatory affairs experience in the medical device industry. Experience with FDA submissions (IDE, PMA, 510(k)) and international pathways (EU MDR, Health Canada, Japan Shonin) preferred. Strong writing, editing, and analytical skills with attention to detail. Proficiency in Microsoft Office and regulatory document tools. Highly organized with the ability to manage multiple projects. Willingness to travel up to 10%.