Project Manager I - Medical Devices

DEKRA North America, Inc.; United States; Remote; USD 120,000 - 190,000; Full time

Benefits offered by this job

Company Health Savings Account/contrib

401(k) plan with employer match

Paid time off

Dental/Vision Insurance options

Life insurance

Job summary

DEKRA North America, Inc. seeks a Project Manager I - Medical Devices to lead regulatory compliance initiatives for medical devices. The role focuses on audits, documentation review, and cross-functional collaboration across R&D, manufacturing, and QA/RA in a remote US setting.

You’ll manage multiple client accounts, deliver timely reports, and contribute to risk assessment and regulatory pathway decisions while aligning with global frameworks and client expectations.

Qualifications

• Bachelor's degree required in a related medical device discipline; MS/PhD preferred but not required.
• 5–10 years in a Notified Body/Accreditation Body environment or equivalent medical device industry experience.
• Experience with CE Medical Device Directives and European frameworks.
• Experience with ISO 13485, MDSAP, MDR, IVDR, UKCA, TCP schemes.

Responsibilities

• Contribute to a safe and healthy work environment by following procedures and policies.
• Review client medical device documentation for regulatory compliance.
• Plan and conduct audits to assess compliance with ISO 13485, MDSAP, MDR, IVDR, UKCA, and TCP.
• Prepare clear, accurate client reports and present findings to clients.

Skills

Regulatory compliance

Project management

Auditing

Communication skills

Cross-functional collaboration

Travel readiness

Education

Bachelor’s degree in Engineering/Biomedical Engineering/Medicine/Pharmacy/Microbiology/Biotechnology/Clinical Physics

MS or PhD preferred

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Project Manager I - Medical Devices

Medical Concord Regular Full Time Professional US Remote, US

3 days ago Requisition ID: 1123

In compliance with applicable pay transparency requirements, the application window for this position is expected to close on November 29, 2026, subject to change based on business need.

We are especially interested in applicants with the following experience: cardiovascular or general non-active experience, including a background in animal tissue

A Day in the Life and the Impact You’ll Make:

This role requires backgrounds in the medical device industry, specifically prior roles in R&D, Manufacturing, Clinical, or QA/RA. Individuals in this role generally hold advanced degrees, e.g., Ph.D. or MSc. The successful candidate possesses knowledge and understanding of the challenges of a medical device manufacturer and is dedicated to sharing their experience and perspective in a professional and constructive manner. Our goal is to seek consensus on solutions while maintaining a focus on compliance.

Leading complex regulatory and technical projects, DEKRA is your global partner in the testing and certification of medical devices. We are one of the five largest Notified Bodies in the world for companies involved in the design, manufacturing, and distribution of medical devices, including high-risk and innovative medical devices and in-vitro diagnostic medical devices. DEKRA is a recognized auditing organization for the Medical Device Single Audit Program (MDSAP). This program is designed to allow a single audit for medical device manufacturers that is accepted in multiple regulatory jurisdictions. As an established, well-recognized certification body, we maintain a global network of offices and state-of-the-art laboratories, taking pride in supporting the worldwide access of medical products to markets including Europe, Taiwan, USA, UK, Canada, Brazil, Australia, and Japan.

What You’ll Do:

• Contribute to a safe and healthy work environment by actively participating, taking responsibility, and following established procedures and policies.
• Review client medical device documentation to assess compliance with applicable European regulatory requirements.
• Apply working knowledge of global regulatory frameworks to evaluate manufacturers’ processes and products.
• Plan and conduct audits to assess continued compliance with ISO 13485, MDSAP, MDD, AIMD, IVD, MDR, IVDR, UKCA, and TCP requirements. Audit assignments include defined target allocations for preparation, execution, and reporting activities, and adherence to established timelines and productivity expectations is required.
• Review product design documentation using STED formats, including engineering and manufacturing records, and clearly document deficiencies or compliance gaps. Completion targets will align with the experience level and scope of assigned reviews.
• Manage a portfolio of approximately 7–12 client accounts, ensuring timely delivery of services and responsiveness to client needs.
• Prepare clear, accurate, and technically sound client reports within defined timelines.
• Present DEKRA’s findings to clients using professional communication and presentation skills.
• Serve as a Level 2 or higher owner of 4–10 DEKRA knowledge modules, maintaining familiarity with assigned content.
• Work with minimal supervision while demonstrating the ability to assess regulatory compliance and escape issues appropriately.
• Analyze regulatory requirements and make sound, supportable determinations regarding compliance pathways.
• Collaborate effectively with external consultants and cross-functional stakeholders to support project objectives.

What You’ll Bring:

• Bachelor’s degree (minimum) in Engineering, Biomedical Engineering, Medicine, Pharmacy, (Micro)biology, Biotechnology, Clinical Physics, or a related medical device discipline. (MS or PhD preferred but not required.)
• 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 the following schemes: ISO 13485, MDSAP, MDD, AIMD, IVD, MDR, IVDR, UKCA, TCP.
• Broad knowledge of engineering principles and technical applications used in the development of medical devices.
• 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 with the ability to manage multiple projects and deliver results on time.
• Proactive mindset, strong organizational skills, and the ability to work independently within established processes.

Physical Considerations:

• Must be able to work in a variety of client locations, environments, and conditions.
• Must be able to accommodate working various shifts as client activities are scheduled.
• Must be able to withstand the rigors of travel.
• May require difficult travel and long periods of driving.
• Ability to move and conduct work with full range of motion.
• Ability to lift 25-50lbs.
• Extended periods of computer-based work
• Extended periods of standing

Travel Considerations:

• Domestic and/or international travel required, estimated up to 35%

What You’ll Receive for the Value You Bring:

Compensation:

The base pay for this position ranges from $120,000 annually to $190,000 annually. Actual pay is based on several factors including market location and position-related knowledge, skills, and experience.

DEKRA North America strives to provide a competitive benefits package to colleagues and promotes physical, emotional, and financial well-being. Colleagues can self-select from our benefits to create a package unique to their needs. These benefits include access to competitive health care and retirement benefits, paid time off, mental health well-being resources, and opportunities to learn and develop. Below is a list of benefits we offer our colleagues:

• Critical Illness & Hospital Indemnity supplemental insurance
• Company Health Savings Account contribution
• Flexible Spending Account for eligible health care and dependent care expenses
• Paid time off such as vacation, sick leave, and floating holidays
• Mental and emotional support resources through our Employee Assistance Program
• Wellness Program to increase activity and health habits, with ability to earn participation rewards
• Travel Assist (Domestic/International)
• Participation in a 401(k) plan, with an employer match
• Company paid Short- & Long-Term Disability benefits
• Group term life insurance with options to buy-up for self and others
• Tax-free Service Awards

Growth and Development Benefits:

• Regional Advancement Program
• Education Assistance Program
• Student Loan Repayment Assistance
• Internal training and development resources to grow your career
• Annual Career Goal Setting and Performance Review cycle participation

This list provides an overview of benefits provided for US-based colleagues; the DEKRA North America Employee Benefits Guide outlines plan details and further related eligibility requirements.

• Reports to: Technical Director
• Work Model:Remote
• Work Location:US-based Remote
• Supervises Others:No
• Status: Full-time; Regular
• FLSA Classification:Exempt
• Visa Sponsorship Eligibility:This position is eligible for Visa Sponsorship.

Growth in DEKRA:

DEKRA colleagues are welcome to apply for any position that is a potential match with their qualifications if performance in their current role is in good standing. The career path following this specific role is as follows:

• Senior Project Manager

About Us:

As a global provider of comprehensive services and solutions, we help our customers improve their safety, security, and sustainability outcomes. DEKRA is the world’s leading testing, inspection and certification (TIC) companies offering innovative professional services in the fields of vehicle inspection, expert appraisals, industrial product testing & certification, management system certifications, leadership consulting, and much more. DEKRA is a purpose-driven organization with a deep passion to make the world a safer place on the road, at work, and at home. In DEKRA, you will be part of a continuously growing organization with a 100-year history involved in more than 50 countries on five continents.

We hope you’ll consider a career with DEKRA North America as we strive to become the Global Partner for a Safe World!

DEKRA North America is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

DEKRA North America is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or accommodation while seeking employment, call [phone]. We will make a determination on your request for reasonable accommodation on a case‑by‑case basis.

DEKRA North America will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay.

DEKRA North America participates in the E-Verify program to confirm eligibility to work in the United States.