Project Manager - Regulatory Operations

Position Overview

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.

Responsibilities

Responsible for 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.

Responsible for the coordination of regulatory intelligence processes

Responsible for assigning and organizing 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.

Responsible for document control

Responsible for updating and controlling procedure documents and forms to ensure accuracy, consistency, and compliance with internal and external standards. Ensure all documents meet established quality and regulatory requirements. Support the management of document lifecycle processes, including version control, review, and approval workflows.

Responsible for Regulatory operation project management

Responsible for organizing project objectives, managing detailed project plans, and establishing 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.

Required Skills and Competencies

• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.  Communicates changes and progress.

• Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.  Demonstrated experience and proficiency with the Microsoft Office products (Word, Excel, PowerPoint, Access, Outlook)

• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

• Analytical - Synthesizes complex or diverse information; Collects and researches data; Interprets internal and external business issues and recommends best practices

• Problem Solving – Solves complex problems; takes a broad perspective to identify innovative solutions.

• English read/write fluency a MUST. A second global language is a plus.

• Excellent ability to generate and maintain accurate records.

 

Required Skills & Behaviors

• Independence – works independently, with guidance in only the most complex situations

• Leadership – may lead functional teams or projects

• Ethics - Treats people with respect; Ability to be honest and trustworthy; Works with integrity and ethically; Upholds organizational values.

• Teamwork – Balances team and individual responsibilities; Integrates continuous feedback loops; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit.  Shares expertise with others.

• Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

• Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

 

Education and Experience

• 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.

• Min 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.
  
  

Additional Information

• The position can be hybrid or in-person at any of our Insulet locations.

• Travel is estimated at 10% but will flex depending on business needs.

 

Additional Information:

The US base salary range for this full-time position is $89,400.00 - $134,100.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.