Join the GMED team today and work on the frontier of Medical Device Innovation!
The European Union recently published a new set of Regulations for the medical device sector. These new 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 Coordinator will safeguard and act as the timekeeper of all qualification projects to ensure successful completion.
Under the supervision of the Talent Acquisition and Qualification 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.
- Records, maintains and updates all qualification files for GMED NA employees;
- Maintains and optimizes the qualification tracking system through the development and use of new tools;
- Applies a systemic filing procedure within the Talent Acquisition and Qualification Unit;
- 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;
- Insures the compliance of the qualification pathway to the regulatory frameworks (EU and MDSAP, …) and explains regulation 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;
- Types and designs accurate and concise briefs, communication memos to include charts, tables, graphs;
- Performs other duties and responsibilities as required or requested or delegated.
- Maintains good knowledge and understanding of the applicable standards and regulations for the performance of her/his tasks as well as scientific and technical knowledge of the medical device in relation with her/his field of intervention;
- Ensures excellent quality of her/his activities for every certification service provided and contributes to the quality assurance of services offered;
- Provides technical assistance within her/his field of intervention as needed and upon request to all parties involved in the certification process, in particular to the Business Development & Marketing Department;
- Contributes proactively to a good team spirit in collaborating effectively with colleagues within her/his department, GMED North America, Inc., and GMED;
- Aims to achieve her/his personal objectives as defined by his/her manager and contributes to reaching the department’s collective objectives;
- Generally, promotes GMED North America, Inc.’s activities and GMED’s good reputation & image, attend conferences or events on behalf of GMED North America, Inc. and/or takes part in the organization of promotional events;
- Contributes to the development of internal or external training programs by identifying training opportunities in her/his field of intervention, building training material, resources or literature, and making training presentations.
Who You Are
- 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 coordination;
- Working in a fast-paced environment.
- Professional experience working with Medical Devices or/and Certification processes within a healthcare agency;
- Experience creating, working and optimizing the use of multiple entry databases;
- Project Management skills.
- 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;
- Thorough and concise;
- 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;
- Ability to create an environment that promotes trust when interacting with the personnel throughout the qualification process.
Who We Are
GMED North America is the US subsidiary of GMED, a leading Certification Organization, a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC) and 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.
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 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.
GMED North America is an Equal Employment Opportunity Employer, committed to a diverse, inclusive, and healthy work environment with a unique culture.
You are strongly encouraged to submit your resume and cover letter.