Sr. Regulatory Affairs Specialist, Omnipod 5 Expansion (Hybrid - Acton, MA)

Position Overview: The Senior Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory registrations and submissions activities including working with Marketing, New Product Development, Manufacturing and Engineering.

Responsibilities:

• Support initiatives to ensure regulatory approval of medical devices in both domestic and international markets.
• Provide regulatory affairs support for all aspects of product development, product manufacturing, and/or clinical studies including pre-market, post-market and physician initiated studies.
• Provide Regulatory support to on-going compliance and corporate initiatives.
• Partner with Marketing and Development teams to provide support to currently-marketed products as necessary.

This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.

• Compile and submit documentation as required in support of marketing initiatives.
• Review marketing and sales promotional materials for regulatory impact, including: • Promotional materials for journals and other media • Trade show booths, materials for distribution • Sales talking points, etc. • Review product packaging and labeling changes for regulatory impact, including: • US labels in English • Review of translations with certified translators • Vendor documentation, certification, and fitness for quality • Represent Regulatory Affairs on project teams and in key meetings and decision making processes regarding labeling and promotion
• Assist with pre-market and post-market filings (510(k), IDE, PMA, PMA updates, CE Marking, Canadian Registrations, EU Registrations, and ROW registrations).
• Prepare submissions and reports for FDA and support other international agencies as required.
• Review submission decisions/content issues with manager.
• Provide assistance in planning, creating, organizing and interpreting regulatory documents for submission to various regulatory agencies.
• Review and approve project documentation such as specifications, procedures, schedules, test protocols and reports, validations, etc. • Evaluate, communicate, and present change assessments to the organization to ensure timely implementation in support of continued compliance
• Review, evaluate and approve Engineering Change Orders (ECO) especially those concerning significant changes and revisions.
• Performs other duties as required.

Education:

and

Experience:

• B.S.:

/ B.A.:

or equivalent combination of

education:

and

experience:

.

Minimum Requirements:

• 5+ years of regulatory medical device industry

experience:

• RAC Certification preferred.
• Knowledge of regulatory guidelines and

requirements:

(domestic and international). Preferred

Skills:

and Competencies: • Effective verbal and written communication

skills:

•

Experience:

with reviewing ECOs,

Requirements:

, and Specification Documents.

• Understanding of 21 CFR 820, CMDR, ISO 13485, MDD.
• Team player ready to work hard on a dedicated team that has the safety of the patient as priority #1.
• Ability to communicate at multiple levels of an organization.
• PC skill, word processing, spreadsheet, database, specifically: Word, Excel, PowerPoint, Visio, Project.
• Ability to organize and manage multiple priorities.
• Ability to generate and maintain accurate records.

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office.

#LI-Hybrid Additional Information:

Compensation:

&

Benefits:

For U.S.-based positions only, the annual base salary range for this role is $89,400.00 - $134,100.00 This position may also be eligible for incentive

compensation:

.

We offer:

a comprehensive

benefits:

package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online.

Actual pay depends on

skills:

,

experience:

, and

education:

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.

(Know Your Rights) Insulet Corporation is proud to be an equal

opportunity:

employer. 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. (Know Your Rights) Insulet employees are all focused on the same goal — to make a difference.

Our relentless passion is to simplify life for people with diabetes. We excite and empower employees to bring their best selves to work through a culture that supports a healthy work and life balance. We set the bar high to meet customer needs, and our priority is to ensure our employees are equipped and supported to help us get there.

We foster and celebrate curiosity, innovation, and learning. Our teams work collaboratively and are empowered to drive the best actions for our customers. Our innovation spirit and customer-centric focus position us as global pioneers — leading the way to improve health outcomes with revolutionary medical devices while breaking down barriers to access.