Staff Clinical Affairs Regulatory Specialist

Introduction to Insulet Corporation

Insulet Corporation, founded in 2000, has been at the forefront of improving the lives of hundreds of thousands of patients worldwide. Our mission is to enable our customers to enjoy simplicity, freedom, and healthier lives through the use of our innovative Omnipod product platform. As a leader in the medical device industry, we are committed to hiring exceptional individuals who share our values and are passionate about making a difference in the lives of others.

Job Overview

We are seeking a highly motivated and experienced Staff Clinical Affairs Regulatory Specialist to join our expanding team. As a key member of our Clinical and Medical Affairs department, you will play a critical role in ensuring that our clinical research studies are conducted and reported in compliance with applicable global regulations. Your expertise in regulatory affairs and clinical research will be essential in driving our business forward and maintaining our commitment to excellence.

Key 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 high-quality regulatory documents to applicable global regulatory authorities, Ethics Committees, and Investigational Review Boards.
• Communicate with regulatory authorities, Ethics Committees, and other organizations to confirm requirements and respond to requests for additional information.
• Oversee and/or prepare high-quality regulatory documents related to the conduct of clinical studies, pre and post-market.
• Develop and update Standard Operating Procedures (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), and Post-market Clinical Follow-up (PMCF) Plans and Reports.
• Review or support the development of clinical documents, such as study protocols, clinical study reports, and annual and interim reports, to ensure regulatory compliance.
• Respond to internal requests for regulatory and clinical research input and collaborate with clinical and other departments regarding global clinical regulatory requirements.
• Lead preparation activities and ensure clinical documentation is readily available for internal and external clinical-related audits/inspections.
• Provide guidance and training to other staff members, with potential direct reports.

Essential Qualifications

• Bachelor's degree (BA or BS) or equivalent combination of education and experience.
• Minimum of 10+ years of related experience in the medical device, biotechnology, or contract research organization industry, with direct experience in regulatory and clinical research.
• Proficiency in guidelines, standards, and regulations 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.

Career Growth Opportunities and Learning Benefits

At Insulet Corporation, we are committed to the growth and development of our employees. As a Staff Clinical Affairs Regulatory Specialist, you will have the opportunity to work on complex and challenging projects, collaborate with cross-functional teams, and develop your skills and expertise in regulatory affairs and clinical research. Our comprehensive training programs and mentorship opportunities will support your career advancement and help you achieve your professional goals.

Work Environment and Company Culture

Our company culture is built on a foundation of shared values, including a passion for innovation, a commitment to excellence, and a dedication to making a difference in the lives of others. We foster a collaborative and dynamic work environment that encourages creativity, teamwork, and open communication. As a remote-friendly company, we offer flexible working arrangements that allow you to work from anywhere, at any time, and maintain a healthy work-life balance.

Compensation, Perks, and Benefits

We offer a competitive salary range of $113,600.00 - $170,750.00, depending on experience and location. Our comprehensive benefits package includes bonus, equity, and a range of perks, such as flexible working arrangements, professional development opportunities, and a supportive and inclusive work environment.

Conclusion

If you are a motivated and experienced regulatory affairs professional looking for a new challenge, we encourage you to apply for this exciting opportunity. As a Staff Clinical Affairs Regulatory Specialist at Insulet Corporation, you will play a critical role in driving our business forward and making a difference in the lives of others. Join our team and be part of a dynamic and innovative company that is committed to excellence and dedicated to improving the lives of patients worldwide.

Apply now and take the first step towards an exciting and rewarding career with Insulet Corporation!

Apply Now