Certification Project Manager - Medical Devices

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

Job Description

This is an exciting opportunity to join GMED NA and work as a Certification Project Manager with Experts, Product Reviewer, Internal Clinician, and Auditor.

This role will ideally suit a candidate with an ability to work well in a team, be highly organized, reliable, and accountable.

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 Certification Unit Manager.

Essential Functions

Project Management:

• Ensures 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, MDSAP) and/or regulatory certification (e.g. CE marking) applicable rules; Acts on behalf of GMED North America, Inc. as the main point of contact for each client s/he has been assigned regarding the certification services provided by GMED, maintains good communication with the client and interacts with all parties involved in each project under completion;
• Ensures effective monitoring of her/his assigned clients’ certification in compliance with reference rules and standards;

Certification Services:

• 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;

Business Development:

• 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

Required Education and Experience:

• Bachelor’s degree in technical related field (Engineering, Bio-engineering, Biomedical Sciences, …)
• 2 years of medical devices industry experience

Preferred Qualifications:

• 4 years of experience in regulatory affairs, product development, research & development, clinical research
• Experience with CE marking, Medical Device Directive, Medical Device Regulation, ISO 13485, MDSAP
• French Speaking

Job-specific Competencies:

• Proficient in project management. Demonstrates and encourages collective responsibility in teams.
• Able to influence through communication-based on logic and reason and to respond constructively to the needs of others. Able to negotiate effectively. Able to command respect at all levels and cultural interfaces.
• Clear, precise, and well-organized
• Detail-oriented
• Strong reliability and accountability
• Able to work independently
• Ability to prioritize and manage multiple priorities effectively, attention to detail
• Flexibility/adaptability: Ability to actively manage ongoing change. Able to adopt means of communication and interaction with people from different cultures.

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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