Join the GMED team today and work on the frontier of Medical Device Innovation!

Reports to: Compliance Director and Qualification Manager

Division: Compliance

Position Classification: Exempt, Full-Time

Fields: Medical Devices, In-Vitro Diagnostics - Healthcare

Location(s): Hybrid (on-site two days per week, Rockville, MD office)


Job Description

 

GMED seeks a Training & Qualification Coordinator to manage and implement training solutions on regulatory and technical topics. In the first year, the role will focus on both training and qualification. The coordinator will oversee training management, identify needs, develop resources, deliver programs, and ensure internal and external client satisfaction. Collaboration across departments is key to enhancing employee skills, productivity, and client retention.

On the qualification side, the role includes administrative and project support tasks such as data management, scheduling, reporting, and maintaining filing systems. Proficiency in Excel, Power BI, Word, and project management is required, along with French language skills for communication.


Essential Functions

Training Process Management:

  • Continuously improves processes for internal and external training activities
  • Identifies, develops and maintains training resources and tools
  • Maintains training database and activities records

Training Solutions Delivery:

  • Identifies and analyzes internal and external training needs
  • Implements training solutions while optimizing costs and resources
  • Timely delivers training programs in line with regulatory and/or business requirements
  • Maintains trainings library

Training Service Development:

  • Supports the company’s Learning & Development training actions deployment
  • Serves as training digital tools administrator and subject-matter expert
  • In collaboration with Business Development and Marketing, benchmarks the market and analyzes the market training solutions to identify and address unmet training needs
  • In collaboration with Business Development and Marketing, defines a strategy for the promotion of GMED NA Training Center services 

Essential Functions: Training

  • Data Entry and Management: Accurately enter, organize, and manage data, ensuring accuracy and confidentiality.
  • File System Development and Maintenance: Create and sustain a well-organized filing system, both electronic and physical, to ensure quick access and secure storage of documents.
  • Meeting Coordination: Schedule all meetings and manage calendars efficiently, including preparing materials and notifying participants.
  • Office Supplies Management: Monitor inventory and place orders for office supplies, ensuring the team has necessary resources.
  • KPI Reporting: Update and maintain KPIs to support performance tracking, utilizing data analysis tools where applicable.

Who You Are

Required Education and Experience:

  • Qualifications & Experience: Bachelor's degree in education or a scientific field with 2+ years of experience in training management or related roles.

  • Training & Regulatory Expertise: Proficient in conventional and digital training methods with familiarity in regulatory environments.

  • Project Management: Skilled in planning, multitasking, and time management, with knowledge of project management frameworks.

  • Technical Skills: Advanced proficiency in Excel, Power BI, and Word for data handling, reporting, and documentation.

Job-specific Competencies:

  • Excellent written and verbal communication skills
  • Leadership skills
  • Organizational and planning skills
  • Project Management
  • Customer-oriented
  • Ability to work in an international environment
  • French fluency is a plus

Who We Are

GMED North America is the US subsidiary of GMED, a leading Certification Organization, a distinguished Notified Body (CE0459) Authorized to act under European Regulation (EU) 2017/745 on medical devices, European Directives 90/385/EEC, 93/42/EEC, 98/79/EC and Regulation n° 722/2012 on products utilizing tissues of animal origin, GMED certifies a vast range of medical devices and in vitro diagnostic medical devices. An Auditing Organization recognized by the MDSAP Regulatory Authority Council. We serve the Medical Device Industry with offices in Europe and the United States.

Our goal is to provide the best in Product Certification and Quality Management Services for medical device manufacturers worldwide. At GMED North America, we strive to the highest standards of professionalism, competency, work ethic, and customer service. All our employees are the cornerstone of this process because their work directly influences GMED North America's reputation.

Aside from our expertise with due diligence, we pride ourselves in our diverse workforces, with employees from different parts of the world.

Our Values:

  • Commitment to Clients and Patients' safety
  • Expertise
  • Reliability
  • Team Work

GMED North America is an Equal Employment Opportunity Employer, committed to a diverse, inclusive, and healthy work environment with a unique culture. GMED North America recruits, employs, trains, compensates, and promotes regardless of race, religion, sex, national origin, ethnicity, age, disability, pregnancy, political affiliation, sexual orientation, gender identity, color, marital status, veteran status, medical condition, and all the other characteristics that make us unique.


What We Offer

At GMED North America, our primary goal is to attract and retain exceptional talent who are not only subject matter experts, but also passionate about upholding the integrity and excellence of our services. We recognize that our success is driven by the expertise and commitment of our team, and we are focused on creating an environment where top professionals can thrive.

GMED North America offers a full and competitive benefits package including group-sponsored health, dental, and vision coverage, flexible spending accounts, short-term and long-term disability, company-paid life insurance, competitive base salary, annual bonus based on company performance, and a 401K retirement program. We promote work-life balance through the option to telework, flexible working arrangements, generous time off program, paid holidays, paid bereavement leave, paid parental leave, commuter benefits program for public transportation, and internet stipend.

We offer growth opportunities within the organization. There are a lot of opportunities and employees are able to apply and move into different roles within the company. We have numerous success stories, and we want you to be one of them.

Thank you for your interest in GMED North America.

We look forward to hearing from you!

#LI-Hybrid

 

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