Program Manager, Regulatory Risk Management

Location: Pittsburgh, PA

Cardiac Management Solutions

The Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest® wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies.

Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. To date, the LifeVest WCD has been worn by hundreds of thousands of patients and saved thousands of lives.

ZOLL has been Pittsburgh’s Manufacturer of the Year, one of Western PA’s Healthiest Employers, and even one of Pittsburgh’s Coolest Offices. But it’s our unique opportunity to impact people’s lives that makes ZOLL the ideal place to build your career.

Job purpose

This position will serve as the subject matter expert on risk management and will lead risk management collaboration throughout the project team and organization This position will be responsible for the implementation of risk management quality documentation. Daily tasks for this role will be based around risk management documentation, risk analysis, failure mode effects and analysis, authoring risk controls and traceability mapping for identified risk controls including their verification of effectiveness, risk based V&V method , residual risk review and risk benefit analysis

Duties and responsibilities

  • Maintain the risk management process including Risk Identification, Risk Analysis, Risk Mitigation, Risk Monitoring and Risk Reduction.
  • Lead the Risk Management activities for assigned projects and establish system risk documentation including the Risk Management Plan, Risk Management Report, Post Market Risk Evaluation etc.
  • Coordinate across functional teams in the development & execution of design risk analyses for Design Plans, Design Reviews, Change Orders and dFMEA, pFMEA and uFMEA.
  •  Advise R&D personnel on risk management activities throughout the product lifecycle. This includes risk management plans and reports, hazard analysis, design and process risk assessment
  • Advise R&D personnel on risk management associated with Corrective & Preventive Actions (CAPA)
  • Drive continuous improvement efforts through facilitating, leading and collaborating with cross functional teams
  • Support risk management audits, as a subject matter expert, when working with external business partners and where needed regulatory authorities
  • Keep abreast of emerging regulatory/industry trends regarding risk management
  • Perform risk assessment as part of post-market monitoring in support of complaint risk analysis, field corrective actions, design changes, product life cycle sustaining efforts, and supplier risk assessment evaluation and manufacturing non-conforming materials
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Qualifications

  • Bachelor's degree in a technical or engineering discipline
  • Must have a minimum of 7 years of risk management design controls, systems engineering, or quality assurance experience in the Medical Device Industry
  • Requires in depth knowledge of 21 CFR 820, ISO 13485 and ISO 14971 requirements.
  • Must have good working knowledge of US FDA regulations for Class II and Class III medical devices.
  • Experience working with EU Notified body is required
  • Cross functional team experience is required

Skills

  • Project Management skills preferred
  •   Must be able to work under pressure to meet regulatory reporting time frames and company requirements
  • Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
  • Knowledge of U.S. and European/International regulations and standards
  • Experience interacting with FDA and/or other regulatory agencies
  • Must work well in team environments
  • Must demonstrate leadership skills in team setting.
  • Proven analytical abilities, able to apply problem-solving skills for problems of moderate to diverse scope
  • Solid understanding of manufacturing, change control and risk management, and an awareness of regulatory trends
  • Understanding of engineering concepts and scientific terminology
  • Experience reviewing technical and design specifications
  • Superior interpersonal skills
  • Excellent communication skills, both oral and written
  • Proven ability to prioritize, conduct, and manage time to meet project deadlines
  • Documented evidence of writing skills

Working conditions

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 The noise level in the work environment is usually quiet.

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.

Supervisory responsibility

NA

AAP/EEO Statement

ZOLL is committed to fostering an inclusive workplace, where unique identities, backgrounds, cultures, perspectives and experiences are respected and valued.

 

 Equal Opportunity Employer – Disability and Veteran

 

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