Product Assessor - Medical Devices (Active & Software)
SGS North America Inc.

Job Info

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Company Description

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 that reviews are technically sound and in compliance with all applicable requirements
• Support in training and qualification of colleague and create training materials
• Ensure adherence to SGS policies, procedures, and processes
• Communication with team members and client with regards to the product assessment or other activities performed
• Minimize risks associated with medical device certification
• 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
• 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
• To assist with queries raised from product assessments
• Work at all times to adhere to KPIs set as an individual and within a team
• Ensure that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery
• Ensure full compliance with the Company's Code of Integrity & Professional Conduct, and act in accordance with SGS policies.
• At all times, adopt a safe behavior by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company's policies and procedures.

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)

Our Benefits

We care about your total well-being and will support you with the following, subject to your location and role.

• Health: Medical, dental and vision insurance, company-paid life, accident and long-term disability insurance, flexible spending accounts
• Wealth: Competitive pay ($134,000-$180,000 USD based on experience), matching 401(k) with immediate vesting upon enrollment, generous employee referral program
• Happiness:
  • Professional Growth: Online training courses, virtual and classroom development experiences, education assistance program
  • Work-Life Balance: Paid-time vacation, sick, company holidays
  • Team Building: Employee engagement and recognition programs, wellness, DE&I initiatives

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.

All your information will be kept confidential according to EEO guidelines.

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