Qualification Project Manager

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

Job Description

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.

Essential Functions

• 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, interacts 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 ensures 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 in Qualification process improvement projects.
• Performs other duties and responsibilities as required or requested or delegated.

Who You Are

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.

Job-specific Competencies:

• Highly proficient in the use of Microsoft Excel (creating dedicated tools, detailed reporting, consolidating, and extracting data for analysis of trends, using accurately multiple Excel functions).
• Comfortable with the use of digital tools that require customization and implementation.
• Good communication skills
• French language preferred.
• 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 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!

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