Technical Specialist - Medical Device Certification

Summary of Position:

This role supports two main activities:

• Coordination of all aspects of the training and qualification process;
• Oversight of intake review process for technical documentation submitted by clients.

The Technical Specialist is an individual contributor who works closely with new hires, technical experts/project managers, and support staff to ensure the efficient completion of qualification activities according to applicable internal requirements. This individual also oversees the intake review process, ensuring that new technical documentation includes all required elements prior to the initiation of regulatory review by technical experts/project managers. The intent of this intake review is to facilitate the timely completion of client projects. Due to the nature of the materials being handed, the Technical Specialist has a general understanding of medical device technologies and associated EU regulatory requirements.

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 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.

Essential Duties & Responsibilities:

• Implement DEKRA's medical device qualification and training systems in a timely and efficient manner to demonstrate a trainee’s competence in applicable regulations and DEKRA procedures and policies. This includes the following activities:
• Identifying Notified Body competency codes based on the background of newly hired staff (technical experts, project managers, auditors);
• Preparing qualification plans around these competency codes, submitting plans for review and approval to stakeholders;
• Organizing projects (technical file reviews, audits) with mentor, technical experts/project manager, support staff, and trainees to ensure the requirements defined in qualification plans are fulfilled;
• Preparing and submitting evidence of completion of qualification requirements for final review and approval to ultimately support qualification of new hires;
• Monitoring trainees progress towards qualification and periodically report on status to management.
• Oversee intake review process for technical documentation submitted by clients to facilitate timely completion of regulatory review to support EU CE marking. This includes the following activities:
  • Verifying required elements of technical documentation are provided, this includes technical reports from design verification and validation, clinical evaluation, etc.;
  • Communicating to the client via the support office when elements are missing or incomplete;
  • Providing complete packet to technical experts/project managers for technical review.

Required Knowledge, Skills & Abilities:

• Ability to learn DEKRA's systems, policies, procedures, and processes
• Broad knowledge of technical applications used in the development of medical devices
• Excellent interpersonal, verbal, written and presentation skills
• Must work well in project teams
• Detail oriented individual
• Proactive attitude and excellent organizational skills and the ability to work autonomously

Required Education & Experience:

• Minimum 4-year degree in either Engineering, Biomedical, (Micro) biology, Biotechnology, Chemistry, Clinical Physics or related discipline of medical devices.
• Minimum of 2 years of progressive, professional experience in Medical Device/Regulatory Affairs field.

Physical Demands: Ability to handle extended periods of computer-based work, including telephone

• Ability to work flexible and long hours, as needed
• Ability to lift 25-50 lbs.

Required Travel:

• Domestic or international travel may be limitedly required, estimated up to 10%.

Benefits:

DEKRA North America strives to provide a competitive benefits package to employees 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, dental, and vision
• 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

Financial Benefits:

• Participation in a 401(k) plan, with an employer match
• Company Paid Short-Long Term Disability benefits
• Flexible Spending Account for eligible health care and dependent care expenses
• Group term life insurance with options to buy-up for self and others.

Growth and Development Benefits:

• Education Assistance Plan
• Internal training and development resources to grow your career
• Annual Career Goal Setting

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

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)