Manager, Post Market Compliance - Global Product Monitoring (Hybrid - Acton, MA)

Insulet Corporation•Acton, MA

13d•Hybrid

About The Position

The Manager, Post Market Compliance-Global Product Monitoring (GPM) will report directly to the Senior Director of GPM-Safety & Surveillance and be responsible for the development, execution, oversight and maintenance of key aspects of Insulet’s Post Market Surveillance System consistent with applicable laws, industry standards and company policies. They demonstrate the ability to execute in a highly regulated, medical technology environment and willingness to perform hands-on, technical and operations work. They work with local and global cross-functional partners and external authorities to ensure effective post-market compliance.

Requirements

Proven ability to: Build solid, collaborative working relationships across all functions.
Produce results as a leader, individual contributor, and as a member of a team.
Exercise judgment against the criteria of applicable regulations and standards.
Rapidly learn and take advantage of new concepts and technologies.
Understand medical/clinical and technical aspects of product.
Quickly assimilate relevant information in unfamiliar situations, identify issues and root causes.
Proven analytical, problem-solving, and critical thinking skills with the ability to synthesize complex data into actionable insights and solutions.
Acquire, query and analyze data with focus on detail.
Respond to emerging issues, manage team assignments, and provide timely direction.
Prioritize and direct limited resources to the most critical areas and issues.
Make commitments, set priorities, and deliver results on time and on budget
Communicate effectively with and influence people at all levels of the organization
Present and transfer knowledge.
Implement and maintain accurate documentation consistent with applicable quality standards.
Fluency in applicable regulations and standards.
Intermediate to advanced computer skills.
BS/BA degree with 8+ years’ work experience with at least 4 years’ experience in post-market surveillance or post-market vigilance in the MedTech industry.
Experience influencing without authority and facilitating cross-functional collaboration.
Experience managing cross-functional task- or project-focused teams on a global basis across different locations and cultures.
Proven experience responding to regulatory authority inquiries.

Nice To Haves

Strong working knowledge of global medical device regulations and standards, including 21 CFR 820, 21 CFR 803, 21 CFR 806, ISO 13485 & 14971, EU MDR, CMDR, and other global regulations, standards, and guidelines (such as MDSAP, IMDRF, MDCG, MEDDEV).
In addition to the above, at least a general knowledge of: diabetes and experience supporting technology and/or medicines related to diabetes.
SAMD and SIMD.

Responsibilities

Develops and maintains product knowledge of existing and new products.
Engages globally with internal stakeholders, developing and maintaining strong relationships to ensure effective processes while identifying improvements to drive efficiency and compliance.
Represents GPM at cross-functional, multi-level, and external meetings.
Adheres to all regulatory compliance and quality standards, including company policies and procedures and U.S. FDA, Health Canada, EU MDR, and other applicable quality system and country-specific regulations.
Maintains awareness of new or revised regulations, standards, and/or guidelines, particularly as they pertain to post-market vigilance and surveillance.
Reviews, evaluates and approves document changes, especially those concerning significant changes and revisions.
Ensures required documentation, records, and reports are complete, accurate, and properly maintained.
Ensures key performance indicators are met or exceeded and works to continually drive down time-to-detect and time-to-resolve through improved detection and rapid response.
Performs other duties as required.
Reports to the Senior Director of GPM-Safety & Surveillance.
Ensure timely and effective management, preparation, and assembly of information for post-market requests for additional information (RFAIs) or other authority inquiries related to marketed products.
Author, co-author, and/or approve response communications to inquiries and requests from regulatory authorities around the world.
Engage with regulatory authorities beyond written communications as needed.
Serve as global process owner for RFAIs and drive global improvements of both the process and supporting technology based on performance data, authority trends, and industry practices.
Focus primarily on regions and markets outside of EMEA but will support EMEA as needed. Will work collaboratively with the French local contact for vigilance (matériovigilance).
Serve as subject matter expert and lead adoption of best practices as it pertains to regulatory writing and engagement with authorities on post-market matters.
Where appropriate, ensure escalation and cross-functional engagement with stakeholders around the world to enable rapid response to emerging issues and opportunities.
Where needed, advise on clinical/technical content in vigilance reports.