Project Manager I – Medical Devices

This is a fully remote position, open to applicants in United States.

📋 Description

• Actively participate in fostering a safe and healthy workplace by taking responsibility and adhering to established procedures and policies.

• Assess client medical device documentation to ensure compliance with relevant European regulatory standards.

• Utilize knowledge of global regulatory frameworks to evaluate the processes and products of manufacturers.

• Organize and carry out audits to maintain compliance with ISO 13485, MDSAP, MDD, AIMD, IVD, MDR, IVDR, UKCA, and TCP requirements.

• Prepare, implement, and report on audit assignments within specified allocations, timelines, and productivity goals.

• Review product design documentation utilizing STED formats, including engineering and manufacturing records.

• Clearly document any deficiencies and compliance gaps identified during assessments.

• Manage approximately 7–12 client accounts, ensuring prompt service delivery and responsiveness.

• Create precise, accurate, and technically sound reports for clients within set timelines.

• Present findings from DEKRA to clients.

• Serve as a Level 2 or higher owner of 4–10 DEKRA knowledge modules, maintaining the assigned content.

• Work with minimal oversight, evaluate regulatory compliance, and appropriately escalate issues as necessary.

• Analyze regulatory requirements and make well-supported determinations regarding compliance pathways.

• Collaborate with external consultants and cross-functional stakeholders.

• Report directly to the Technical Director.

• Travel domestically and/or internationally, estimated up to 35%.

⛳️ Requirements

• A minimum of a Bachelor’s degree in Engineering, Biomedical Engineering, Medicine, Pharmacy, (Micro)biology, Biotechnology, Clinical Physics, or a related medical device field.

• 5–10 years of experience in a similar position within a Notified Body/Accreditation Body, or a combination of education and relevant experience in the medical device industry.

• Strong foundation in design engineering or manufacturing.

• Experience in global regulatory affairs, including CE Medical Device Directives and related European regulations.

• Familiarity with or management experience in one or more of ISO 13485, MDSAP, MDD, AIMD, IVD, MDR, IVDR, UKCA, and TCP standards.

• Comprehensive knowledge of engineering principles and technical applications relevant to medical device development.

• Exceptional interpersonal, verbal, written, and presentation skills.

• Proven ability to work effectively within project teams.

• Comfort in presenting findings to client leadership and mid-sized audiences.

• Strong analytical and problem-solving abilities.

• Capacity to manage multiple projects and deliver results punctually.

• Proactive attitude combined with strong organizational skills.

• Ability to work independently within established processes.

• Flexibility to adapt to various client locations, environments, and conditions.

• Willingness to accommodate various shifts based on client activities.

• Ability to endure travel demands, including challenging trips and extended periods of driving.

• Capability to move and perform tasks with a full range of motion.

• Ability to lift weights ranging from 25 to 50 lbs.

• Proficiency in performing extended periods of computer-based work and standing.

• Travel required, both domestically and internationally, estimated up to 35%.

• Eligible for visa sponsorship.

• Must be authorized to work in the United States through DEKRA’s E-Verify process.

🏝️ Benefits

• Medical and prescription health care benefits.

• Dental and vision benefits, including coverage for Domestic Partners.

• Supplemental insurance for Critical Illness and Hospital Indemnity.

• Contributions to a Company Health Savings Account.

• Flexible Spending Account for eligible health care and dependent care expenses.

• Paid time off encompassing vacation, sick leave, and floating holidays.

• Access to the Employee Assistance Program for mental and emotional support.

• Participation rewards through the Wellness Program.

• Paid Parental Leave.

• Assistance for domestic and international travel.

• 401(k) plan with employer matching contributions.

• Company-paid short- and long-term disability benefits.

• Group term life insurance with options for additional coverage.

• Tax-free Service Awards.

• Regional Advancement Program.

• Education Assistance Program.

• Support for Student Loan Repayment.

• Internal training and development resources available.

• Participation in the Annual Career Goal Setting and Performance Review cycle.

• Opportunity for remote work.