Training and Qualification Project Manager

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

Reports to: Training & Resources Qualification Department 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)

Summary/Objective:

The Training and Resource Qualification Project Manager will safeguard and act as the timekeeper of all training and qualification projects to ensure successful completion.

Under the supervision of the Training and Resources Qualification Department Manager, he/she applies a project management approach and methodology to monitor the evolution and completion of project milestones for every qualification file. Using dedicated tools, he/she will plan, implement, record, and maintain the qualification pathway to meet the company needs and for each profile ensure that they align with our internal processes, the regulations, and the company’s evolutions.

He/she will be dealing with a variety of technical profiles whose background can vary greatly depending on their degrees and industry experience, and shall exert independent judgment when setting priorities, juggling the workload, to optimize the qualification practices, while improving the use of dedicated tools.

He/she will manage and implement training solutions on regulatory and technical topics. He/she will oversee training management, identify needs, develop resources, deliver programs, and ensure internal and external client satisfaction.

Qualification:

• Manages end-to-end qualification projects for technical staff, ensuring timely completion of all key milestones.

• Maintains and improves the tracking system and digital tools to support qualification processes.

• Plans and coordinates qualification-related activities, including meetings and working groups.

• Streamlines, proposes and/or drives improvements to qualification workflows,

• Ensures regulatory compliance of the qualification pathway (Regulations, ISO 13485, MDSAP).

• Acts as liaison with internal teams and HQ experts; prepares clear communications, presentations, and reports.

• Handles sensitive candidate information and supports other duties as needed

• Performs other duties and responsibilities as required or requested or delegated

• Update and maintain KPIs to support performance tracking, utilizing data analysis tools where applicable.

Training:

• Maintains resources (people and training materials), tools, and records.

• Delivers training programs based on identified needs for internal and externals.

• Manages training digital platforms.

• Contributes to Learning & Development actions and helps promote training services with Marketing and Business Development.

• Update and maintain KPIs to support performance tracking, utilizing data analysis tools where applicable.

Job Specific Competencies:

• Project Management


• Ability to follow direction, handle multiple projects and meet challenging deadlines


• Impartial, discreet and ability to manage confidential information


• Self-starter who works well independently but also in various group settings


• Comfortable with the use of digital tools


• Customer-oriented


• Ability to work in an international environment

Required Education and Experience:

• Bachelor’s degree or equivalent in related fields such as biomedical or medical engineering, biotechnology, public health, pharmacy, quality assurance (QA) and regulatory affairs or other relevant fields


• 3 years of experience in project management.


• Working in a fast-paced environment.


• Professional experience working with Medical Devices or/and Certification processes within a healthcare agency or manufacturer preferred.


• Experience creating, working and optimizing the use of multiple entry databases preferred.

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.

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!