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 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.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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