The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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The Auditor, Medical Devices will support the Business Assurance business by leading and/or participating as an assessor during all phases of a client’s management system, in accordance with the company’s accredited certification program. The Auditor is the primary interface with the client before and during the process of all auditing activities. Additionally, the Auditor will help train provisional Auditors through witness audits, will provide technical support and education of both client and sales force as needed. We’re looking for somebody with a minimum of 6-10 years of full-time work experience in a medical device related industry.
This will be a full-time remote/home-based position, with extensive travel to client sites required (approx. 75%).
Audit client management systems for compliance with established standards, client, and/or industry requirements, government regulations, and other relevant standards, specifically ISO 13485, regulatory requirements for the US, Canada, Japan, Australia, and/or Brazil, and/or GMP regulatory requirements related to the medical device, pharmaceutical and/or cosmetic industry.
Assist clients with questions relevant to the audit and/or certification process.
Act as Lead Auditor or team member.
Coordinate audit activity with team members.
Liaison with client regarding audit activity.
Review client's quality management system documentation
Verify and document evidence of compliance and non-compliance.
Prepare audit report.
Review audit results with coordinator and other assessment team members. Make presentations to clients and/or certification board concerning audit results, when required.
Assist with corrective action requirements resulting from assessments.
Participate in audit meetings.
Review audit reports and provide technical assistance to the medical team.
Support management in areas of continuous improvement.
Provide management with updates on status of work, initiatives, and projects, as required.
Travel will include overnight/multiple days, to various worksites and client locations.
In-depth knowledge of auditing management systems in the medical device industry sector, demonstrated through a combination of education and experience:
4 year college/university degree in a science or technical field (biology or microbiology; chemistry or biochemistry; computer and software technology; electrical, electronic, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics) or equivalent combination of relevant education and work experience.
A minimum of 4+ years of full-time work experience in a medical device or related industry.
Completed Lead Auditor training for any standard (preferably ISO 13485), but will train if needed.
Training in quality management systems and/or relevant regulatory requirements.
Strong communication and interpersonal skills.
Sound judgment, organizational, and analytical skills.
Excellent computer and writing skills.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to exercise effective time management skills in completion of assignments.
Must be willing and able to travel extensively. Primarily domestic travel, some international travel may be needed.
Related 3rd party auditing industry management systems experience.
Working knowledge of relevant regulatory requirements for medical devices and pharmaceuticals in the EU, US, Australia, Japan, Brazil, and/or Canada.
Experience implementing/auditing to ISO 13485, ISO 14971, and medical device, pharmaceutical, and/or cosmetic regulatory requirements.
Specific experience/training on processes used in the relevant industry’s manufacturing (ex. sterilization).
Training/experience in quality tools (Kaizen, lean manufacturing, etc.).
Working experience in a wide range of medical devices.
This role requires the ability to:
Ascend or descend ladders, stairs, ramps, and the like, using feet and legs and/or hands and arms. Body agility is emphasized.
Stand, for sustained periods of time.
Walk, moving on foot to accomplish tasks and to move from one work location to another.
Communicate well, thru spoken word, conveying detailed accurate information & instructions to others.
Hear well, perceiving sounds with or without correction, including the ability to receive information thru oral communications.
Exert up to 10 pounds of force occasionally and/or negligible amounts of force frequently to lift, carry, push, pull or otherwise move objects.
Have close visual acuity to perform an activity such as preparing & analyzing data, viewing a computer monitor, reading, report writing, visual inspection, and use of measurement devices.
Additional Salary Information: We offer a salary and benefit package competitively placed within the local market, including medical, dental, vision, life, disability, 401(k) with company match, tuition reimbursement and more.
A career with Intertek means joining a global network of professionals dedicated to bringing quality and safety to life. Our vision is to become the world’s most trusted partner for Quality Assurance and we offer our employees the chance to make an impact with attractive growth opportunities in this industry on a global scale.
We are an Equal Opportunity Employer and do not discriminate against applicants due to veteran status or on the basis of disability. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, or gender identity.
Intertek is a drug-free workplace. As a condition of employment, all hires are required to pass a pre-employment drug test
Internal Number: 210000GJ
Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices with over 43,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection, and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace, and passion, enables our customers to power ahead safely.
The Business Assurance group of Intertek provides a full range of business process audit and support services, including management systems certification, custom supplier audits, and training. Our range of services helps to ensure customer management systems are optimized to facilitate successful growth.