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Project Manager (Medical Device Regulation)

Swoon Deerfield, IL
  • Expired: over a month ago. Applications are no longer accepted.

In collaboration with cross functional teams, the incumbent provides guidance and subject matter support to RA project teams to facilitate regulatory compliance for EU MDR (EU Medical Device Regulation) in the most effective risk-based method. Provides leadership and guidance and subject matter support to offshore and onshore project contractors.

  • In collaboration with cross functional teams, will be responsible for driving global device labeling initiatives to support the EU MDR remediation project objectives.
  • Develop and execute global regulatory labeling strategies and plans for complex projects including new products and ongoing global compliance for products already on market. Understand and incorporate key labeling requirements and best practices into global labeling strategies.
  • Formulate and drive global labeling traceability requirements within project and product teams.
  • Represent or lead the RA labeling function on assigned cross-functional project teams and projects to develop global device labeling requirements and labeling content. Contribute independent ideas and help guide the overall effectiveness of the cross-functional labeling team.
  • Monitor applicable global regulatory and labeling requirements; assure compliance with Baxter and external standards and help drive implementation across functions and projects.
  • Effectively assess impact of emerging global labeling regulations and requirements and help implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance.
  • Effectively perform labeling gap analysis and propose solutions. Develop and document sound regulatory decisions and justifications.
  • Develop and maintain effective cross-functional partnerships and network within RA and key stakeholders including Marketing, R&D, QA, Supply Chain to drive key EU MDR labeling strategies and initiatives.
  • Ensure project teams and business objectives and deliverables are aligned with project regulatory labeling strategy
  • Lead group of regulatory professionals in labeling gap assessments to EU MDR requirements and the further development of labeling requirements documents per MDR project timelines
  • Provide direct supervision and mentoring of project team members during the project. Provide project performance feedback to the team members supervisor/manager
  • Assist in the formulation and execution of regulatory strategies/ project plans
  • Develop and communicate guidance for EU MDR, global and regional regulatory and customer labelling requirements.
  • Monitor evolving regulatory requirements and ensure compliance programs are appropriate and meet requirements
  • Perform labeling gap assessments and provide remediation guidance and strategies
  • Develop and review labeling requirement specifications for remediated products
  • Monitors work output of contractors to define and execute additional training
  • Develop and report periodically metrics for assigned work projects.
  • Assist in the formulation and execution of regulatory strategies/ project plans
  • Develop and communicate guidance for EU MDR, global and regional regulatory and customer labelling requirements.
  • Monitor evolving regulatory requirements and ensure compliance programs are appropriate and meet requirements
  • Perform labeling gap assessments and provide remediation guidance and strategies
  • Develop and review labeling requirement specifications for remediated products
  • Monitors work output of contractors to define and execute additional training
  • Develop and report periodically metrics for assigned work projects.

Qualifications:

  • Extensive knowledge of medical device regulatory requirements for the EU MDR (Medical Device Regulation), and other global Device Labeling requirements.
  • Ability to identify and communicate potential compliance issues and escalate as necessary.
  • Prudent risk taker.
  • Strong business acumen.
  • Strong oral, written communication and presentation skills.
  • Demonstrated interpersonal skills including strong negotiation and facilitation skills. * * Demonstrated leadership skills and experience with coaching others.
  • Strong project management and organizational skills.
  • Proven track record on delivering large scale projects.
  • Ability to manage complex projects and timelines in a matrix team environment.

Education / Experience

  • Bachelor's degree in biological sciences, engineering or related field preferred.
  • Five or more years experience in medical device Regulatory Affairs. Direct experience with global device labeling will be an advantage.
  • Minimum of five years professional experience managing people or projects.
  • Regulatory Certifications such as RAPS a plus

Swoon

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