Project Manager I – Medical Devices

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🇺🇸 United States – Remote

💵 $120k - $190k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

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DEKRA North America

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🚘 Automotive

💼 Consulting

🏥 Healthcare

Automotive • Consulting • Healthcare

DEKRA North America is the U. S. and North American arm of DEKRA, a global safety-solutions provider that offers testing, inspection, certification, auditing, and consulting services across industries. The company provides vehicle inspections (oil changes, emissions, safety stations), product testing and certification (medical devices, consumer and industrial electronics, connected/automotive products), management-system audits and ISO certifications, EHS and process-safety consulting, cybersecurity and EV/connected vehicle testing, and training programs. DEKRA serves automotive and mobility clients (OEMs, dealers, collision ecosystem), manufacturers, medical device companies, utilities/industrial clients, insurers, and enterprises seeking compliance, safety, and sustainability services. Globally DEKRA has ~48,000 employees and around €4. 3 billion in revenues; DEKRA North America emphasizes safety, compliance, and testing services tailored to vehicle mobility, industrial sites, and regulated products.

📋 Description

• Contribute to a safe and healthy work environment by participating actively, taking responsibility, and following established procedures and policies • Review client medical device documentation for compliance with applicable European regulatory requirements • Apply working knowledge of global regulatory frameworks to evaluate manufacturers’ processes and products • Plan and conduct audits for continued compliance with ISO 13485, MDSAP, MDD, AIMD, IVD, MDR, IVDR, UKCA, and TCP requirements • Prepare, execute, and report audit assignments within target allocations, timelines, and productivity expectations • Review product design documentation using STED formats, including engineering and manufacturing records • Document deficiencies and compliance gaps clearly • Manage approximately 7–12 client accounts and ensure timely service delivery and responsiveness • Prepare clear, accurate, and technically sound client reports within defined timelines • Present DEKRA findings to clients • Serve as Level 2 or higher owner of 4–10 DEKRA knowledge modules and maintain assigned content • Work with minimal supervision, assess regulatory compliance, and escalate issues appropriately • Analyze regulatory requirements and make supportable determinations regarding compliance pathways • Collaborate with external consultants and cross-functional stakeholders • Report to the Technical Director • Travel domestically and/or internationally up to an estimated 35%

🎯 Requirements

• Bachelor’s degree (minimum) in Engineering, Biomedical Engineering, Medicine, Pharmacy, (Micro)biology, Biotechnology, Clinical Physics, or a related medical device discipline • 5–10 years of experience in a similar role within a Notified Body/Accreditation Body environment, or a combination of education and relevant medical device industry experience • Strong background in design engineering or manufacturing • Experience in global regulatory affairs, including CE Medical Device Directives and related European frameworks • Experience working within or managing one or more of ISO 13485, MDSAP, MDD, AIMD, IVD, MDR, IVDR, UKCA, and TCP schemes • Broad knowledge of engineering principles and technical applications used in medical device development • Excellent interpersonal, verbal, written, and presentation skills • Ability to work effectively within project teams • Comfort presenting findings to client leadership and mid-sized audiences • Strong analytical and problem-solving skills • Ability to manage multiple projects and deliver results on time • Proactive mindset and strong organizational skills • Ability to work independently within established processes • Ability to work in varied client locations, environments, and conditions • Ability to accommodate various shifts based on client activities • Ability to withstand the rigors of travel, including difficult travel and long periods of driving • Ability to move and conduct work with full range of motion • Ability to lift 25–50 lbs • Ability to perform extended periods of computer-based work and standing • Domestic and/or international travel required, estimated up to 35% • Visa sponsorship eligible • Must be eligible to work in the United States through DEKRA’s E-Verify process

🏖️ Benefits

• Medical and prescription health care benefits • Dental and vision benefits, including Domestic Partners • Critical Illness and Hospital Indemnity supplemental insurance • Company Health Savings Account contribution • Flexible Spending Account for eligible health care and dependent care expenses • Paid time off including vacation, sick leave, and floating holidays • Employee Assistance Program mental and emotional support resources • Wellness Program with participation rewards • Paid Parental Leave • Domestic and international Travel Assist • 401(k) plan with employer match • Company-paid short- and long-term disability benefits • Group term life insurance with options to buy up • Tax-free Service Awards • Regional Advancement Program • Education Assistance Program • Student Loan Repayment Assistance • Internal training and development resources • Annual Career Goal Setting and Performance Review cycle participation • Remote work

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