SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

SGS is seeking a MDSAP Technical Pack Reviewer to conduct reviews of MDSAP reports and approve or raise queries based on technical and procedural knowledge.  This position will ensure that reviews are technically sound and in compliance with all applicable regulations, standards, guidelines, and Competent Authority expectations and that the highest level of service is provided to the customer.

• Maintain up-to-date understanding of MDSAP requirement, including all jurisdiction requirements, regulatory transmittals, MDSAP Audit Approach manual, and all associated standards
• Maintain up-to-date understanding of the MDSAP grading system, corrective and preventive action, and use of the NGE form
• Review MDSAP audit packs according to specified requirements
• Generate Query Sheets for any noted deficiencies in the MDSAP audit pack
• Review and accept/reject query corrections
• Submit final approved documents to the Global MDSAP administrator for submission to REPS
• If approved as an AO submitter, make submissions to REPS as required
• Submit final approved document to Applaudd and approve the MDSAP pack
• Approve MDSAP certificates after technical approval.
• Maintain on-time reviews based on regulatory requirements
• Determine final approval for MDSAP audit packages and the issue of MDSAP certificates
• Signature authority for final MDSAP reports and NGE
• Ensure full compliance with the Company’s Code of Integrity & Professional Conduct, and act in accordance with SGS UK’s Equality & Diversity Policy and ensure others do so.
• Participate in achievement of KPIs
• At all times, adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures.

EDUCATION AND EXPERIENCE

• Bachelor's degree in a related field, Quality, Business Administration, etc.
• 4+ years professional experience in the field of healthcare products or related activities, such as in 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.
• Lead Auditor Qualification

KNOWLEDGE/ SKILLS/ ABILITIES

• Experience as Medical Device audit Technical Reviewer
• Medical device knowledge/codes
• Good communication techniques through electronic mediums
• Good written English skills (as reports will be reviewed/queried in English)  
• Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
• Candidates must demonstrate excellent verbal and written communication skills including grammar and composition.
• Ability to work well with others & independently.
• Proven time management skills and a strong attention to detail.
• Works well under pressure.
• Extended hours and shift work may be required from time to time.
• Travel to other SGS locations or client location may be required from time to time.
• Ensures full compliance with the company’s Health & Safety, Code of Integrity, and Professional Conduct policies.

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.