Insulet Corporation-posted 2 months ago
$89,400 - $134,100/Yr
Full-time • Mid Level
Acton, MA
Miscellaneous Manufacturing

The Project Manager, Reg Ops, role will partner closely with Director, Regulatory Affairs Operations & Intelligence, to support regulatory intelligence activities that ensure compliance of new and currently marketed products, taking into consideration current and proposed changes in regulatory requirements and standards globally. Providing support to administrative registration activities to facilitate timely regulatory submissions and market authorization/approvals. The Project Manager, Reg Ops role leads coordination efforts with cross-functional stakeholders for regulatory intelligence activities to evaluate regulatory impacts, support compliance strategies, and facilitate timely implementation. This role manages regulatory-related projects, tracking performance metrics, and ensuring alignment across teams and stakeholders. This includes leading document control processes to ensure quality and compliance of procedural documentation and supports regulatory operations project management. The position plays a critical role in maintaining regulatory readiness and supporting market authorization efforts for new and existing products.

  • Proactively keep abreast of changes in global laws, regulations, standards/guidance and assess their impact and make recommendations to ensure compliance and provide regular reporting across the organization on key developments that impact product and/or processes and/or business directly.
  • Coordinate regulatory intelligence processes.
  • Assign and organize assessments of global laws, regulations, standards, and guidance with cross-functional stakeholders to ensure timely evaluation and alignment.
  • Track implementation activities and follow up with stakeholders to ensure completion and accountability.
  • Monitor and report on key performance indicators (KPIs) to measure effectiveness and identify areas for improvement.
  • Maintain tracking and trending activities to support strategic decision-making and continuous improvement.
  • Manage document control processes.
  • Update and control procedure documents and forms to ensure accuracy, consistency, and compliance with internal and external standards.
  • Support the management of document lifecycle processes, including version control, review, and approval workflows.
  • Organize project objectives, manage detailed project plans, and establish timelines and milestones to ensure successful execution.
  • Allocate resources effectively and ensure project teams have the necessary tools and information to meet deliverables.
  • Assemble and govern project teams, facilitate communication, and resolve conflicts to maintain momentum.
  • Identify potential risks and develop mitigation strategies to minimize impact on outcomes.
  • Monitor project progress, track KPIs, and provide regular updates to stakeholders to ensure transparency and alignment.
  • B.S./B.A. (4-year Degree) and/or an equivalent combination of education and experience/background in life sciences, technical (engineering) or related field.
  • Minimum 3 years of Medical Device Regulatory Affairs experience.
  • Familiarity with International Regulations (e.g., US FDA 21 CFR 820, EU MDR 2017/745 and IMDRF/GHTF) required.
  • Experience with regulatory data management systems preferred.
  • English read/write fluency a MUST. A second global language is a plus.
  • The US base salary range for this full-time position is $89,400.00 - $134,100.00.
  • Salary ranges are determined by role, level, and location.
  • Individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.
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