Project Manager - Medical Device Expert

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

This role requires backgrounds in the medical device industry, mostly 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 are 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 helping our client’s gain worldwide access to markets including Europe, Taiwan, the USA, Canada, Brazil, Australia, and Japan.

What You’ll Do:

• Access and review client’s medical device files for regulatory requirement for European markets.
• Utilize knowledge of regulatory requirements and apply to manufacturers’ processes and products.
• Audit manufacturers ensuring continued compliance to MDD, AIMD, IVD, MDR, IVDR, etc.
• Review product design, documenting any deficiencies, review engineering and manufacturing using STED formats. 
• Audit experience to include ISO 13485 and MDSAP.
• Create reports for clients utilizing analytical skills, technical knowledge, and excellent written communication skills.
• Utilize professional presentation skills while meeting with clients to present DEKRA’s findings.
• Work with minimal supervision, able to assess compliance to the regulatory requirements.
• Analyze complex regulatory requirements and make sound determinations of the proper course of action.
• Work with external consultants utilizing positive interactive skills.

What You’ll Bring:

• Education:  Minimum 4-year degree in either Engineering, Biomedical, Medicine, Pharmacy, (Micro) biology, Biotechnology, Clinical Physics, or related discipline of medical devices. MS degree or PhD in related field preferred but not required.
• Experience: Minimum of 7-10 years in a similar role in the Notified/Accreditation Body Industry, or combination of education and experience in the Medical Device field.
• Strong background in either design engineering or R & D.
• Global Regulatory Affairs background including CE Medical Device Directives.
• Experience with one or more MDD, AIMD, IVD, MDR, IVDR.
• Broad background in medical devices
• Broad knowledge of engineering and technical applications used in the development of medical devices.
• Excellent interpersonal, verbal, written and presentation skills.  Must work well in project teams.
• Strong analytical skills while handling multiple projects, delivering results on time using well developed problem-solving skills.
• Pro-active attitude and excellent organizational skills and the ability to work autonomously. 

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: 

DEKRA North America’s compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $126,000 annually in our lowest geographic market up to $164,000 annually in our highest geographic market.  Actual pay is based on several factors including market location and position-related knowledge, skills, and experience. 

Benefits:

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:

Health & Well-being Benefits:

• Health care benefits: medical & prescription, dental, vision (including Domestic Partners)
• 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
• Paid Parental Leave
• Travel Assist (Domestic/International)

Financial Benefits:

• 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:

• 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. 

Additional Position Details:

• 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 near 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, please email dekra.hr.na@dekra.com, or call +1 (770) 971-3788. We will make a determination on your request for reasonable accommodation on a case-by-case basis.