Certification Project Manager - Medical Devices

G-MED NORTH AMERICA, Inc.•Rockville, MD

6h•Hybrid

About The Position

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.

Requirements

Bachelor's degree in technical related field (Engineering, Bio-engineering, Biomedical Sciences, etc.)
2+ years of medical devices industry experience
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 the means of communication and interaction with people from different cultures.

Nice To Haves

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

Responsibilities

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.
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 and 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.