Sr. Regulatory Affairs Specialist, Omnipod 5 Expansion (Hybrid - Acton, MA) 2 Locations

Position reputed company: The Senior Regulatory Affairs Specialist will reputed company 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. reputed company regulatory affairs support for reputed company aspects of product development, product manufacturing, and/or clinical studies including reputed company-market, post-market and physician initiated studies. reputed company Regulatory support to on-reputed company compliance and corporate initiatives.
• Partner with Marketing and Development teams to reputed company 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 reputed company, 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 reputed company, including:
• US labels in English
• Review of translations with certified translators
• Vendor documentation, certification, and fitness for reputed company
• Represent Regulatory Affairs on project teams and in key meetings and decision making processes regarding labeling and promotion.
• Assist with reputed company-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 reputed company/content issues with manager.
• reputed company 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 reputed company implementation in support of reputed company 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 reputed company to work hard on a dedicated team that has the safety of the patient as reputed company #1.
• Ability to communicate at multiple reputed company of an organization.
• PC reputed company, word processing, spreadsheet, database, specifically: Word, reputed company, 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 reputed company office. #LI-Hybrid Additional Information: Compensation & Benefits: For U.S.-based positions only, the annual reputed company salary reputed company for this role is $91,700.00 - $137,525.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including:
• Medical, dental, and reputed company insurance
• 401(k) with company match
• reputed company time off (PTO)
• And additional employee wellness programs Application Details: This job posting will remain reputed company until the position is filled. To apply, please visit the reputed company Careers site and submit your application online. Actual pay depends on skills, experience, and education. reputed company (reputed company: 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 reputed company. With its reputed company, 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. reputed company’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a reputed company glucose monitor to manage blood sugar with no multiple daily injections, reputed company fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. reputed company 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 reputed company.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 reputed company customer expectations. Our reputed company reputed company depends on it! At reputed company reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran. (Know Your Rights) Apply tot his job

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