Technical Advisor

NAMSA
Northwood, OH / Remote
30+ days ago

Job Description

NAMSA pioneered the industry, NAMSA was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry.

We have become the industry’s premier provider. We provide support for clients during every step of the product dev elopment lifecycle and beyond.

Come and work for an organization whose:

  • Mission is to make a scientific contribution to every medical device in the world.
  • Culture is passionately committed to the partnership between one another and our clients to improve a nd save lives through a respectful, trusting, and collaborative environment.
  • Values have stood the test of time.
  • Above all else, conduct ourselves with integrity

Job Description:

Principal Duties and Responsibilities

  • Achieve high quality of service at assigned location, consistent with the MRO service model, to ensure the highest level of Client satisfaction. Maintains relationships with Associates in Operations, Sales & Marketing, and fellow Technical Advisors in order to maximize Client satisfaction to support an outstanding Client experience.
  • Plays the primary role in preparing proposals for a minimum of one core laboratory functional area – advising, developing and costing proposals, ensuring accuracy and timely delivery, excellent communication and responsiveness throughout the process.
  • Responsible for the technical and regulatory review and accuracy of proposals they generate, in compliance with ISO 17025 requirements, including an understanding of the intended clinical use of the test article being quoted.
  • Works with other Technical Advisors and/or SME’s, where appropriate, to assure that technical content of the proposal is sound and meets the client’s requirements.
  • Revises proposals, where appropriate, based upon laboratory input and/or Client request.
  • Collaborates with subject matter experts/operational management on costing & design of any “special” proposals for delivery to the Account Manager or Account Specialist.
  • Assures that technical justification for any proposal generated (ODF, email documentation, etc.) is appropriately saved and available to the Operations team.
  • Works closely with Account Specialists, Account Managers and the Area Sales Director to achieve regional sales targets.
  • Develops and maintains strong, professional relationships with clients.
  • Provides technical direction to Associates in the sales and marketing team and within the NAMSA organization.
  • Identifies opportunities at an early stage in conversations with clients and assures these opportunities are passed to the appropriate Account Manager.

Qualifications and Skills

  • Bachelor’s degree in scientific discipline or 3+ years of relevant experience required.
  • Previous experience in a related field preferred.
  • Basic understanding of the Product Development Life Cycle.
  • Firm understanding of the sales process preferred.
  • Demonstrated ability to establish and maintain relationships with clients and internal Associates.
  • Working knowledge of standards, sales and proposals.
  • Some travel required 10%.
  • Fluency in English and local language, if different, required.

Technical Competencies

  • Knowledge of ISO, GLP, GMP, GCP, AAMI, ASTM, European and USP standards/regulations relating to medical device development.
  • Demonstrated knowledge of scientific applications, GLP regulations (if applicable), experimental design, data evaluation, metric system, and technical writing.
  • Familiarity with medical device development process from pre-clinical to commercialization.

Working Conditions

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Requires maintaining physical condition necessary for walking, standing, or sitting for prolonged periods of time.

Position descriptions are not intended, and should not be construed to be an exhaustive list of all responsibilities, skills, and efforts or working conditions associated with a job. NAMSA reserves the right to revise duties as needed.

Source

https://www.indeed.com/jobs

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