Medical Device Technical Scheme Manager

NSF is a globally recognized organization for public health standards. We conduct testing, auditing, and certification, supported by accredited labs. Additionally, we provide top-tier consulting and training for brands and businesses. We are seeking an experienced Medical Device Technical Scheme Manager. You will play a pivotal role in leading the development and ongoing management of the Medical Devices certification scheme programs according to NSF and accreditation body requirements. As the Technical Scheme Manager, you will be responsible for the technical development of certification scheme documents and managing the application of certification scheme requirements ensuring compliance with relevant KPI expectations. You’ll be the primary contact, leading assigned schemes, working directly with teams to ensure the successful delivery of scheme services and providing superior customer service.

Responsibilities

• Lead monitoring and effectiveness of the scheme and identify opportunities to drive topline performance and growth
• Ensure that the medical device program meets all corporate and accreditation requirements for QA and QC turnaround times, production and annual budget
• Plan, organize, and conduct key events including client events, annual conferences, and other trainings events
• Develop and publish case studies, webinars, and industry market evaluations
• Manage and provide certification approvals for responsible schemes, and conduct onsite witness audits, and evaluate programs, and auditor performance
• Support the achievement of new accreditation within given timelines, while maintaining current program accreditation, working closely with accreditations bodies, and NSF’s quality and legal departments
• Deliver audits in line with KPIs
• Work with stakeholders to strategically market and sell service offerings with the most growth potential. Participate in marketing activities with publication goals as necessary
• Support the sales of scheme services by delivering presentations to manufacturers, trade associations, regulatory agencies, and product user groups
• Represent NSF at trade shows, meetings and conferences
• Develop policies and procedures for assigned program areas
• Provide technical expertise to internal and external customers

Qualifications

• You must be a certified Lead 13485 Auditor. Candidates without current certification will not be considered
• 10+ years’ experience with Medical Device auditing programs
• Bachelor's Degree in related field (may substitute 4 additional years of work experience for degree)
• 2+years of supervisory and/or leadership experience
• Technical knowledge of Medical Device schemes and the associated management and development processes
• Experience writing technical documents with a focus on quality systems
• Excellent time management, organizational skills, and attention to detail
• Exceptional verbal and written communication skills
• Proficient in Microsoft Office Suite, i.e. Word, Excel, PowerPoint, Outlook, and Oracle base applications, etc.
• Demonstrated ability to work well with people as a colleague, peer, team member, and leader
• Strong problem-solving and analytical skills

Travel Requirements

• Willingness and ability to travel domestically and internationally up to 25% time

About Us

NSF is a growing global public health and safety organization. Our mission is to protect and improve human and planet health by enabling safe food, clean water and life-enhancing health technologies and products for millions of people around the world. We do so by developing standards, testing, auditing, certifying, and providing advisory services to clients in the food, water, health sciences and consumer industries.

Our nearly 3,000 employees provide services in over 180 countries through many of our global offices, at our 35,000 client sites, from home offices and in state-of-the-art laboratories. We’re growing fast and expanding into new areas such as sustainability and digital. And that’s where you come in. Come join a team that makes a difference in the world. More information about NSF can be found at nsf.org

One of our core values is We Are One NSF. This means that while we’re one team, we embrace the cultural, ethnic, language and demographic diversity that reflects the societies in which we live and work. NSF is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, color, religion, sex, sexual orientation, gender identity, national origin, age, status as a protected veteran, or disability.

About The Team

NSF International Strategic Registrations (NSF-ISR) offers comprehensive management systems certification to internationally accepted standards for quality assurance, safety, sustainability and environmental protection, and information security for a wide range of industries, including automotive, aerospace, food, health sciences, water, and forestry. Our client-focused teams have deep industry expertise and are committed to supporting the journey to certification by adding value at every stage, helping to empower organizations to drive process and performance improvements for products, people, and the planet.