Staff Clinical Affairs Regulatory Specialist (Remote/Flexible)

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod?product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

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!

Job Title: Staff Clinical Affairs Regulatory Specialist

Department: Clinical and Medical Affairs

FLSA Status: Exempt

Position Overview:
This position will be responsible for the identification and evaluation of regulatory requirements and the creation of high-quality regulatory documents associated with conducting global clinical research studies (both pre and post-market studies), and collaborate cross-functionally to ensure clinical research studies are being conducted and reported on in compliance with applicable global regulations.
Responsibilities
? Identify, evaluate, and communicate cross-functionally, the regulatory landscape for conducting clinical research in geographies of interest.
? Support clinical studies and business initiatives by attending meetings, providing required clinical regulatory inputs and deliverables, and proactively identifying and mitigating complex hurdles.
? Prepare and submit to applicable global regulatory authorities, Ethics Committees, Investigational Review Boards, relevant clinical documentation, including but not limited to human research applications, waivers, safety reports, progress reports, final reports, etc.
? Communicate with regulatory authorities, Ethic Committees and other organizations to confirm requirements, as appropriate for the submission of documentation and respond to requests for additional information, collaborating cross-functionally to align strategies and develop innovative solutions.
? Oversee and/or prepare high-quality regulatory documents related to the conduct of clinical studies, pre and post market.
? Oversee and/or prepare clinical documents such as safety plans, safety reports, protocol deviation plans, investigator brochures, and other documents or reports as required by regulatory authorities and/or study protocols.
? Create and update appropriate SOPs to ensure continued compliance with local and foreign regulations.
? Oversee the development and management of clinical data including Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-market Clinical Follow-up (PMCF) Plans and Reports, etc in liaison with other departments in compliance with applicable regulatory requirements.
? Review or support the development of clinical documents such as study protocols, clinical study reports, annual and interim reports, and other clinical documents as required to ensure regulatory compliance.
? Respond to internal requests for regulatory and clinical research input, and clinical documentation to support commercial license/approval submissions, publications and technical presentations, and collaborate with clinical and other departments regarding global clinical regulatory requirements (EU MDR, MEDDEV 2.7/1, MDCG).
? Develop other clinical related required regulatory documents as needed.

? Leads preparation activities and ensures clinical documentation is readily available for internal and external clinical related audits/inspections.
? Provide guidance and training of other staff members; role may have direct reports.
Education and Experience
? BA or BS degree or equivalent combination of education and experience
Minimum Requirements include:
? 10+ years of related experience at medical device, biotechnology or contract research organization with direct experience in regulatory and clinical research including the writing of clinical study documentation, regulatory submissions/responses, and global clinical study reporting requirement responsibilities including safety reporting
? Proficiency in guidelines, standards and regulations that are applicable to medical devices and medical device clinical trials, including 21CFR803, 21CFR812, MDCG 2020-10/1, ISO 14155, EU MDR 2017, ICH GCP and country-specific regulatory requirements
? RAC Certification preferred

Preferred Skills and Competencies: ? Expertise in MS Word & Excel and PowerPoint. ? Demonstrated analytical skills and interpretation of regulations ? Excellent verbal and written communication skills ? Strong initiative, sense of urgency, and commitment ? Strong organizational skills with the capacity to prioritize and multi-task Travel Requirements: ? This position requires some travel up to 10% of the time (domestic and international).

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote

Additional Information:
The US base salary range for this full-time position is $113,600.00 - $170,750.00. 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.

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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