Director, Regulatory Affairs

Job Title:     Director, Regulatory Affairs 

Department:     Regulatory Affairs and Compliance

Manager/Supervisor:    Sr. Director, Regulatory Affairs

FLSA Status:     Exempt

Position Overview: 
This position is integral to Insulet’s global expansion initiatives through the development of Regulatory Strategies, planning and coordination of International Registrations and submissions.  The successful candidate will work with local and global cross functional partners and Regulators to build and execute robust plans that grow the existing business and launch new and innovative products in new global regions.  This role is responsible for managing a variety of activities which lead to and maintain regulatory approvals and compliance for Insulet’s innovative medical devices.   This role provides leadership and partners closely with Marketing, R&D, Manufacturing, Quality and Engineering functions and project teams.

Responsibilities: 
•    Initiate and influence the business strategy by conceptualizing and driving innovative approaches that are aligned with business goals that will help us achieve timely market approvals worldwide.  
•    Work with Regulatory, R&D and Marketing management in planning, organizing and preparing regulatory documents for submission to governmental regulatory agencies: Medical Device License Applications, Establishment Registrations, Technical Files, Device Listings, CE marks, IDEs, Pre-submissions, 510(k)s, Post-market Surveillance, and other regulatory agency documents, as required.
•    Develop, gain consensus and execute a clear Regulatory Vision including; strategic planning and activity with respect to regulatory requirements and the submission of regulatory documents to achieve market approvals with worldwide regulatory authorities.  
•    Provide leadership, participate in, and support project teams.  Review and approve project documentation such as procedures, schedules, protocols and reports, as necessary.
•    Participate and provide regulatory input/guidance in product development (Design Control, Essential Requirements, Harmonized standards, and related activities).
•    Interface with Notified Bodies, FDA and other global regulators, etc., as necessary.
•    Review changes in international laws and regulations and assess their impact and make recommendations to ensure compliance.
•    Review, evaluate and approve Document Changes, especially those concerning significant (from a regulatory perspective) changes and revisions.
•    Work with Marketing and others to develop compliant product labeling. Review and approve product labeling for compliance with regulatory requirements.
•    Maintain Regulatory records and files.
•    May manage, or collaborate with other departments or participate in, the design, documentation, and implementation of clinical trial studies, human factors studies, or user evaluations.
•    Performs other duties as required.

Education and Experience:

Minimum Requirements:
•    B.S. or B.A. and/or an equivalent combination of education and experience.
•    RAPS Certification (RAC) is preferred.
•    8 - 12 years of medical device Regulatory Affairs experience.
•    5 years direct Management experience.
•    Direct experience with US (Class II or higher) device clearance required; experience with international regulatory bodies required.
•    Experience in other worldwide (Asia, Eastern Europe, Latin America, South America, Australia, etc.) regulatory approval processes is desired.
•    Experience in dealing directly with foreign regulatory bodies and FDA is required.
•    Experience in prioritizing and exercising sound judgment in RA matters is required.
•    Must have analytical skills, be detail oriented and have good interpersonal skills.
•    Prior experience with electromechanical/in-vitro diagnostic devices is strongly.    

Preferred Skills/Competencies: 
•    Excellent written and effective verbal communication skills.
•    Proficient project management skills.
•    Ability to communicate at all levels of an organization.
•    PC skill, word processing, spreadsheet, database.
•    Internet search and utilization.
•    Flexible and able to work in a fast-paced environment.
•    Team player.
•    Ability to organize and judge priorities.
•    Excellent ability to generate and maintain accurate records.

Additional Information:

The US base salary range for this full-time position is $169,275.00 - $253,912.50. 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