envelope  Contact us

phone1-301-495-0477

Certification Project Manager - For Medical Devices Certification

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

Location(s): North Bethesda, MD
Contract Type: Perm Full-Time
Fields: Medical Device, In Vitro Diagnostics – Healthcare
 

Interested in working with a team of technical experts in the Medical Device Industry to gain experience and advance in your career with GMED North America? If Yes, we would love to hear from you.

Job description

Summary

The Certification Project Manager’s main mission is to manage and coordinate for each client s/he has been assigned in relation with her/his field of intervention all activities related to the certification services provided by GMED in conformance with GMED’s quality policy for certification, certification quality manual, certification quality plans, and related applicable procedures for certification. This position will report directly to the CPM Unit Manager.

Essential Functions

· Ensure smooth completion of the certification process by having all required steps performed in due time regarding the issuance, surveillance, renewal, and/or withdrawal of certification, as per the voluntary (e.g. ISO 13485) and/or regulatory certification (e.g. CE marking) applicable rules;
· Act on behalf of GMED North America, Inc. and GMED as the main and direct contact for each client s/he has been assigned regarding the certification services provided by GMED, maintain good communication with client and interacts with all parties involved in each project under completion;
· Maintain good knowledge and understanding of the applicable standards and regulations necessary 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;
· Ensure good quality control of her/his activities for every certification service provided and contribute to the quality assurance of services offered;
· Provide 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;
· Generally promote GMED North America, Inc.’s activities and GMED’s good reputation & image, attends conferences or events on behalf of GMED North America, Inc. and/or takes part in the organization of promotional events;
· Contribute 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

Qualifications and Education Requirements:

· Master’s degree in technical related field (Non-Actif, IVD)
· 4 years’ experience in the Industry

Competencies:

1. Detail orientated
2. Must demonstrate strong professionalism skills such as reliability and accountability
3. Project Management
4. Advanced Team-building skills
5. Technical Capacity
6. Communication Proficiency/ Client satisfaction
7. Problem Solving/Analysis

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 an important part 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 work forces, with employees from different parts of the World.

Our Values:

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

What We Offer:

We offer an excellent benefits package including a group-sponsored health, dental and vision coverage, short-term and long-term disability, a company-matched 401k plan, a 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.

Salary: $65,000-75,000 depending on the seniority. You are strongly encouraged to submit a copy your transcripts together with your resume and your application letter. Must be able to work without a need for Visa sponsorship. We look forward to hearing from you!

Apply Today

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

Get a quote proposal

   1-301-495-0477

clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors, and Resources Qualification Manager For Medical Devices Certification