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

Job Description

The Certification Unit Manager (Active MD Unit) position is responsible to guide and manage a team of Certification project Managers, Lead Auditors and Product Reviewers (including Internal Clinicians) assigned to this Unit while reporting to the Certification Department Director. A major part of this position is to ensure continuous development and growth of the units’ resources, client base and adherence to the company’s processes, procedures and policies, provide a proactive interface between the internal and external customers and the certification staff to ensure effective delivery of the certification process. To do so, strong business analyst and project management skills are essential.


Essential Functions

Department Management:

  • Directly supervises subordinate managers and team members. Communicates areas of accountability and performance expected of personnel assigned based on the given frame and the approved budget according to the organization’s policies and applicable laws in both onsite and remote settings.
  • Defines with the Certification Director, the strategic long-term development and structure evolution of the department and the unit including identifying resource requirements and needs ensuring resource optimization and utilization.
  • Responsible for interviewing, hiring, terminating, training, and developing, planning, assigning, and directing work; appraising performance; addressing complaints and resolving problems.
  • Fosters a favorable working relationship with all external resources and internal employees to promote a cooperative and harmonious working environment that will be conducive to maximum employee morale, productivity, and efficiency/effectiveness.
  • Constructs and administers the budget for assigned business unit.

Customer Focus:

  • Enhancing company customer service reputation with external & internal customer.
  • Responsible for the overall unit’s customer communication to ensure clarity and visibility during the different stages of the services
  • Proactively analyzes and presents trends and deploy global solutions in coordination with management.

Monitoring and Reporting:

  • Monitors, analyzes, and reports monthly, quarterly, and annual individual and unit KPIs and deploys key actions to solve issues short and long
  • Monitors, analyzes, and reports client base status (health) monthly, quarterly, and annually and deploys key actions in coordination with management.
  • Monitors, analyzes, and reports monthly, quarterly, and annual unit road map implementation status and deploys key actions to ensure deliverables within the budget and timeframe.

Quality:

  • Incorporates company standards of excellence into daily work to foster a quality environment and demonstrates personal commitment to excellence.
  • Ensures unit adherence to company quality processes, procedures, and best
  • Ensures that the deliverables, communication, and projects adhere to the highest quality standards in terms of form, content, filing, and archiving with the support of stakeholders.

Regulatory:

  • Ensures the unit is current on all the regulatory aspects of the business, services, and industry, fostering self-training and proactively seeking internal and external training when needed or based on a forecast of upcoming regulatory shifts on key regulatory topics within the budget and productivity limits.
  • Participates in producing regulatory content as it relates to the unit’s field of
  • Represents the unit during the audits/inspections (internal and external).
  • Responsible for the unit’s adherence to the regulatory requirements of our NB status and Accreditation and AO status.

Technical:

  • Continuously evaluates, analyzes, and reports the technological strengths and improvement points of individuals to maintain relevance to their clients’ devices, technologies, and certification schemes.
  • Assigns client portfolio in line with the individual’s core
  • Assesses the individuals based on the core competencies of the department and provides a pathway for developing SMEs based on the companies’ criteria, department needs, and Including assignment of tasks, deliverables, KPIs, and capacity.
  • Responsible for projects/decisions of the priorities of qualification and extension/maintenance of qualification of the units’ resources. Including but not limited to the maintenance of the individual’s competency files, qualification files, conflict of interest files, service log, and qualification memos.

Development:

  • Works directly with the BDM (Business Development and Marketing) team to provide support during the prospection phase and to increase visibility, market share, and client base stability for the assigned unit.
  • Assists in developing divisional plans, goals, objectives, policies, and procedures in coordination with the management of other units and Committee of Directors.
  • Responsible for the units’ technical capabilities answering to the needs of the client base (present and future), the requirements of accreditation and designation (present and future).

Branding:

  • Generally, promotes GMED North America, Inc.’s activities and its good reputation & image, attend conferences or events on behalf of GMED North America, and/or takes part in the organization of educational/information 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 with Unit members.
  • Fosters innovative projects to increase the visibility of our expertise and values.

Productivity:

  • Assigns, monitors, and reports the capacities of each individual on a monthly, quarterly, and annual basis with proactive efforts to ensure optimized utilization.
  • Ensures utilization of all resources in a manner that serves the business, clients, and bottom line whether it is during the qualification process or after qualification of the resource.

Who You Are

Required Education and Experience:

  • Master’s degree in a technical/scientific field – preferably medical devices
  • Please refer to GMED NA policy in regards of MDR requirements
  • Strong ability to work in an international environment, including parent company and international
  • Ability to read, analyze and interpret common scientific and technical journals, financial reports, and regulatory, quality, and technical documents.
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or business community.
  • Ability to write & deliver speeches and articles for publications while conforming to prescribed style and format.
  • Ability to effectively present information to top management, public groups, and/or boards of directors.
  • 2 years of previous experience in management

Job-Specific Competencies:

  • Detail orientated
  • Must demonstrate strong professionalism skills such as reliability and accountability
  • Project Management
  • Advanced Team-building skills
  • Technical Capacity
  • Communication Proficiency
  • Problem Solving/Analysis

Certifications and Qualifications:

  • MDR, MDD
  • QMS ISO 13485:2016 or ISO 9001:2015
  • Risk Management or ISO 14971:2019

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 and 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

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 hav e 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.

We look forward to hearing from you!