DEKRA North America is looking for a Technical File Reviewer to join our Medical Certification Team. DEKRA’s Technical Document Reviewers have strong backgrounds in European Regulatory Requirements (MDD, MDR) and deep knowledge of the Quality System Standards (ISO 13485). In this role, you will interact with the administrative, project, and leadership teams as well as with our clients in order to assess their technical files and design dossiers. You will be tasked with performing detailed investigations of complex technical issues. Utilizing available knowledge, resources, and tools, our aim is to maintain customer loyalty by being strict but fair during the review process while building strong relationships.

DEKRA is one of 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. At DEKRA North America, you will be part of a growing organization with a near 100-year history employing over 45,000 employees in more than 60 countries around the globe.

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 clients gain worldwide access to markets including Europe, Taiwan, the USA, Canada, Brazil, Australia, and Japan.

What You'll Do:

• Develop and execute medical test plans (MTP).
• Conduct technical file reviews utilizing analytical skills and technical knowledge, record the review findings, and prepare the client report; all in a timely manner.
• Communicate with the client about technical issues and the progress of the review.
• Utilize knowledge of regulatory requirements to manufacturer’s processes and products.
• Review product design, engineering, and manufacturing while documenting any deficiencies.
• Apply knowledge of applicable product standards and horizontal standards.
• Maintain proficiency on global regulatory requirements and develop and maintain rapport with regulatory reviewers and project team members.
• Involve experts (clinical, sterilization, etc.), as needed, in the execution of product reviews and in accordance with standards and regulations.
• Perform administrative tasks in projects as required.
• Work under directed supervision of a Certified Senior Project Manager.

What Makes a Great Candidate:

• Broad knowledge of engineering and technical applications used in the development of medical devices.
• Ability to assess compliance with regulatory requirements.
• Strong analytical and problem-solving skills.
• Ability to develop collaborative, working partnerships with clients (both internally and externally) and on project teams.
• Strong commitment to principles of client excellence; demonstrating a strong client service orientation in all interactions and activities
• Confidence in exercising judgment with the ability to identify situations requiring the expertise of others.
• Excellent organizational skills and the ability to work autonomously while balancing multiple priorities.
• Strong sense of urgency including the ability to meet or exceed deadlines, set priorities to handle multiple projects simultaneously delivering results on time in an efficient and effective manner.
• Utilized polished, professional presentation skills while communicating with clients to present DEKRA’s findings
• Comfortable with scheduling and conducting work over the phone, conference calls, and multi-media platforms including video conference calls - Zoom, Skype, Teams, etc.
• Excellent communication skills in both verbal and written presentation formats.

Required Education and Experience:

• Minimum 4-year degree in either Engineering, Biomedical, Medicine, Pharmacy, (Micro) biology, Biotechnology, Clinical Physics, or related discipline of medical devices.
• Minimum 7 years of progressive, professional experience in the Medical Device/Regulatory Affairs field.
• Provide a detailed File Review/Design Dossier Review Log inclusive of the following details: dates; product type and general description; NBOG code; classification.
• Provide evidence of relevant training (e.g., MDD, IVDD, product categories, technologies, clinical evaluation, technical documentation review), these may take the form of training certificates from 3rd party organizations or from a previous employer
• Provide abstracts with clear identification of the associated NBOG codes (i.e., Publications, Patents).

Desired Experience:

• Strong background in either design engineering or R&D.
• Global Regulatory Affairs background including CE Medical Device Directives.
• Clinical or medical experience in cardiovascular applications.
• Experience with sterilization.
• Broad background in medical devices.
• FDA 510(k) experience .

Physical Considerations:

• Ability to work in a general office environment.
• Ability to handle extended periods of computer-based work, including telephone.
• Ability to lift 25-50 lbs.

Travel Considerations:

• Domestic and/or international travel required, estimated up to 10%.

Benefits:

DEKRA North America strives to provide a competitive benefits package to colleagues and promotes the 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.

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

Qualifications

Behaviors

Preferred

Team Player : Works well as a member of a group

Loyal : Shows firm and constant support to a cause

Innovative : Consistently introduces new ideas and demonstrates original thinking

Functional Expert : Considered a thought leader on a subject

Enthusiastic : Shows intense and eager enjoyment and interest

Detail Oriented : Capable of carrying out a given task with all details necessary to get the task done well

Dedicated : Devoted to a task or purpose with loyalty or integrity

Motivations

Preferred

Work-Life Balance : Inspired to perform well by having ample time to pursue work and interests outside of work

Self-Starter : Inspired to perform without outside help

Financial : Inspired to perform well by monetary reimbursement

Peer Recognition : Inspired to perform well by the praise of coworkers

Job Security : Inspired to perform well by the knowledge that your job is safe

Growth Opportunities : Inspired to perform well by the chance to take on more responsibility

Goal Completion : Inspired to perform well by the completion of tasks

Flexibility : Inspired to perform well when granted the ability to set your own schedule and goals

Ability to Make an Impact : Inspired to perform well by the ability to contribute to the success of a project or the organization

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)