Project Manager I

DEKRA North America hires a Project Manager I to lead regulatory and technical projects for medical device clients. The role reviews documentation, plans and conducts compliance audits, manages client accounts, and reports findings against applicable regulatory requirements.

Responsibilities:

• 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 escalate 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

Requirements:

• This role requires backgrounds in the medical device industry, specifically prior roles in R&D, Manufacturing, Clinical, or QA/RA
• The successful candidate possesses knowledge and understanding of the challenges of a medical device manufacturer
• 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 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
• MS or PhD