Product Assessor - Medical Devices Active Software - MDA0303 MDA0307 MDA0315 MDA0316

We are currently seeking a highly skilled and detailoriented Product Assessor (Medical Devices Active & Software) 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.

• Regulation (EU) 2017/2185 Codes:
  • MDA0303 Active nonimplantable devices utilizing hyperthermia/hypothermia
  • MDA0307 Active nonimplantable respiratory devices
  • MDA0315 Standalone software
  • MDA0316 Medical gas supply systems and parts thereof
• 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 deskbased but occasionally may be onsite) 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 Companys 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 Companys policies and procedures.

Qualifications :

Education

• Bachelors 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.
• Knowledge of the following Technical File codes desirable (as per Commision Implementing Regulation (EU) 2017/2185 of 23 November 2017:  
  • MDA303  Active nonimplantable devices utilizing hyperthermia / hypothermia 
  • MDA0307 Active nonimplantable respiratory devices
  • MDA0315 Standalone software
  • MDA0316 Medical gas supply systems and parts thereof
• Active Medical Devices knowledge:
  • Standalone software devices etc. through designing manufacturing or testing of such devices
  • Nonimplantable device for monitoring 
  • Nonimplantable device for monitoring vital physiological parameters
  • Nonimplantable devices utilizing hyperthermia / hypothermia
  • Nonimplantable surgical device
  • Nonimplantable devices for medical gas supply systems and parts thereof
• Thorough knowledge and understanding of related standards: EN 60601 EN 62304 EN 62366 etc.
• 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 wellbeing and will support you with the following subject to your location and role.

• Health: Medical dental and vision insurance companypaid life accident and longterm disability insurance flexible spending accounts
• Wealth: Competitive pay $134000$180000 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
  • WorkLife Balance: Paidtime 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 companys 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 online employment application because of a disability please callfor 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.

Remote Work :

Yes

Employment Type :

Fulltime