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SGS Consulting
Rutherford, NJ | Full Time
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SGS LLC
Rutherford, NJ | Full Time
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SGS Consulting
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Product Assessor - Medical Devices
SGS LLC Rutherford, NJ
$104k-131k (estimate)
Full Time | Business Services 2 Weeks Ago
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SGS LLC is Hiring a Product Assessor - Medical Devices Near Rutherford, NJ

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. Job Description

We are currently seeking a highly skilled and detail-oriented Product Assessor to join our team. In this position, you will be responsible for conducting technical file reviews against the European Medical Device Directive and Medical Device Regulation for Class I/IIa/IIb and/or Class III medical devices. Your role will involve supporting CE marking activities carried out by SGS, including support of team with technical queries.

  • Ensure regulatory compliance of product technical file assessment under applicable EU Medical Devices
  • Directives and /or Regulations and those for UKCA
  • Conduct product assessments (primarily desk-based, but occasionally may be on-site) in accordance with established procedures, maintaining a high standard of service delivery.
  • Ensure that reviews are technically sound and in compliance with all applicable requirements.
  • Support in training and qualification of colleague and create training materials.
  • Communicate with team members and client with regards to the product assessment or other activities performed
  • Minimize risks associated with medical device certification.
  • Maintain personal competence and development in qualified specialist areas to be able to assess product technical documentation on an ongoing basis.
  • Project manage assessments as appropriate, to maximize efficiencies, enhance client satisfaction, and
  • ensure compliance with requirements.
  • Assist with queries raised from product assessments.
  • Work to adhere to KPIs set as an individual and within a team.
Qualifications

Education

  • Bachelor’s degree in engineering, medicine, pharmacy, information technology, or other relevant studies

Experience

  • 4 years professional experience in the field of healthcare products or related activities, such as in design, manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
  • Active Medical Devices knowledge:
    • Stand-alone software devices, etc. through designing, manufacturing, or testing of such devices
    • Non-implantable device for monitoring
    • Non-implantable device for monitoring vital physiological parameters
    • Non-implantable devices utilizing hyperthermia / hypothermia
    • Non-implantable surgical device
    • Non-implantable devices for wound and skin care
  • Thorough knowledge and understanding of related standards: EN 60601, EN 62304, EN 62366, etc.
  • Knowledge of the following Technical File codes desirable (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017): MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and MDA0318.
  • Broad range of competency codes and previous technical documentation review experience
  • Understanding of the clinical application of the technology
  • Experiences in cybersecurity and AI

Skills & Knowledge

  • Experience with:
    • European Medical Device Directive (93/42/EEC) and Regulation (EU) 2017/745 (Medical Device Regulation)
    • Key EU harmonized medical devices standards e.g. EN 14971:2019, EN 14155:2020
    • European Medical Devices Nomenclature (EMDN)
    • Medical device knowledge on MDA/MDN/MDS codes listed in Commission implementing regulation (EU) 2017/285
  • Good communication techniques through electronic mediums
  • Good written English skills (as reports will be reviewed/queried in English)
Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$104k-131k (estimate)

POST DATE

08/28/2024

EXPIRATION DATE

09/25/2024

WEBSITE

sgscorp.net

HEADQUARTERS

ANN ARBOR, MI

SIZE

25 - 50

FOUNDED

2013

CEO

ANDREW GERING

REVENUE

<$5M

INDUSTRY

Business Services

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About SGS LLC

What We Do SGS combines innovative engineering solutions with professional inspection services in the ever-evolving industries of telecom and construction. Founded on the belief that a great business is built by establishing and fostering lifelong relationships with our clients, we operate with a focus on direct communication and pride ourselves on quick turnarounds. Our internal process streamlines each project from conception to completion. SGS provides the peace of mind that project managers need, with the quality of product industry leaders demand. Why We Do It We are passionate about cult...ivating an environment where our employees can thrive, and our clients can be successful. Taking pride in our work, we continually aspire to push the boundaries of procedural and engineering efficiencies, with our vision toward shaping the future of industrial systems and engineering standards. We are invested in each and every client because we believe that growth is a result of successful partnerships. How SGS Began After decades in the industry, we came to a realization not every company is created equal. From workflows and deliverables, to client communication, we wanted to do things more efficiently. When SGS was founded in 2013, we made a commitment to provide a better work environment for our employees, where we did things for the right reasons, and recognized the contributions of our colleagues in the industry. Today we are still energized and committed to that goal, maintaining superior standards and best practices along the way. SGS has quickly grown to become a leader in the industry, and the higher we climb, the more grounded we become. Now a full-service engineering firm, we offer nationwide inspections, construction, and geotechnical services to the biggest names in telecom and construction. We know that by doing things right the first time, fostering a healthy culture, and taking pride in our work, our customers will reap the benefits. More
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