Join the GMED team today and work on the frontier of Medical Device Innovation!
Location(s): North Bethesda, MD (Hybrid)
Reports to: Qualification Department Manager
Division: Compliance Department
Position classification: Exempt, [TBF1] Full Time
Fields: Medical Devices, Active Medical Devices – Healthcare
The European Union recently published a new set of Regulations for the medical device sector. These Regulations reinforce the pre-requisites and on-going pathway to qualify and maintain competences for the technical personnel involved in the evaluation of Medical Device technologies.
The Qualification Project Manager will safeguard and act as the timekeeper of all qualification projects to ensure successful completion.
Under the supervision of the 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 with the workload, to optimize the qualification practices, while improving the use of dedicated tools.
- Coordinates the qualification projects for technical personnel, managing from start to finish the follow up of all key milestones, within defined and scrutinized timelines, to guarantee successful completion.
- Maintains and optimizes the qualification tracking system through the development and use of new tools.
- Manages the scheduling and planning of the Unit relating to the qualification pathway, including qualification meetings, conferences, working groups.
- Suggests and improves the qualification tasks workflow to increase efficiency.
- Acts as a Liaison with other team members, interact with Department Unit Managers and Technical Experts located in our Headquarters in Paris.
- Handles highly confidential and non-routine information relating to candidate files.
- Ensures the compliance of the qualification pathway to the regulatory frameworks (EU and MDSAP, …) and explains regulation to candidates when necessary.
- Creates and coordinates presentations relating to Qualification processes and ensure dissemination of information within the organization.
- Assesses and implements digital qualification tools as needed.
- Creates accurate and concise briefs, communication memos to include charts, tables, graphs.
- Develop and/or participate to Qualification process improvement projects
- Performs other duties and responsibilities as required or requested or delegated.
WHO YOU ARE
Required Education and Qualifications:
- 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
- Experience creating, working and optimizing the use of multiple entry databases.
- Highly proficient in the use of Microsoft Excel (creating dedicated tools, detailed reporting, consolidating, and extracting data for analysis of trend, using accurately multiple Excel functions).
- Comfortable with the use of digital tools that require customization and implementation.
- Good communication skills
- French language
- Meticulous and detail-oriented.
- Exceptional organizational skills.
- Ability to follow direction, handle multiple projects and meet challenging deadlines.
- Self-starter who works well independently but also in various group settings.
- Team player, reliable and focused on core missions.
- Impartial and discreet when managing confidential information.
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 and due diligence, we pride ourselves in our diverse workforces, with employees from different parts of the World.
- Commitment to Clients and Patients' safety
- Team Work
WHAT WE OFFER
We offer a competitive benefits package including group-sponsored health, dental and vision coverage, short-term and long-term disability, 401k plan, company-paid life insurance, paid holidays and time off program providing our employees with great work-life balance. We offer growth opportunities within the organization. There are a lot of opportunities and employees can apply and move into different roles within the company. We have numerous success stories, and we want you to be one of them.
GMED North America is an Equal Employment Opportunity Employer, committed to a diverse, inclusive, and healthy work environment with a unique culture.
Applicants responding to this posting must be able to provide proof of eligibility to work in the United States.
You are strongly encouraged to submit your resume and cover letter. We look forward to hearing from you!