Manager, Global Vigilance Writing - Remote/Flexible Opportunity with a Leading Medical Device Company

Join Our Team: Revolutionizing Diabetes Management through Innovative Technology

Insulet Corporation, a pioneering medical device company, is seeking a highly skilled and experienced Manager, Global Vigilance Writing to join our expanding team. As a remote/flexible professional, you will play a crucial role in developing and maintaining quality assurance methodologies, systems, and medical device industry best practices that meet customer, regulatory, and client requirements.

About Insulet Corporation

Since its inception in 2000, Insulet has been driven by a mission to enable customers to enjoy simplicity, freedom, and healthier lives through the use of our Omnipod product platform. Over the past two decades, we have improved the lives of hundreds of thousands of patients by leveraging innovative technology that is wearable, waterproof, and lifestyle-accommodating. Our continued success depends on hiring amazing people guided by shared values who exceed customer expectations.

Job Summary

The Manager, Global Vigilance Writing will serve as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives. This role requires a strong and diverse skillset in relevant areas to drive success. You will be responsible for overseeing global assessment, follow-up, coding, and vigilance activities, as well as managing the quarterly periodic summary reporting process.

Key Responsibilities

• Oversee the global assessment, follow-up, coding, and vigilance activities for complaints determined to be reportable
• Ultimately responsible for oversight, peer review, and approval of vigilance reports to ensure on-time submissions to the appropriate regulatory authorities
• Manage the quarterly periodic summary reporting process
• Oversee the day-to-day vigilance reporting assignment and support management in day-to-day operations in a fast-paced work environment
• Lead, provide instruction, and feedback to the team as needed
• Collaborate with engineering, complaint investigation laboratory, medical, and other internal staff to review events, coding, and investigation results to support regulatory reporting compliance
• Lead departmental non-conformances escalated into CAPA System
• Serve as a subject matter expert for post-market and complaint handling regulatory questions and inquiries
• Understand the principles of scientific writing and convey messages in a clear and concise manner
• Apply comprehensive knowledge of relevant regulatory requirements and corporate policies to assess document requirements and identify information gaps or other potential issues
• Lead internal and external audits and inspections
• Manage special projects as assigned
• Perform other duties as required

Education and Experience

To be considered for this role, you must have:

• A Bachelor's degree and 5 years of demonstrated experience in medical device complaint evaluation and reportability determination, or 5 years clinical experience in diabetes management or an appropriate combination of relevant education and experience
• Prior management experience leading remote teams

Preferred Qualifications

The ideal candidate will possess:

• Demonstrated medical device complaint handling and vigilance reporting experience
• Working knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and demonstrated knowledge of country-specific differences and requirements
• Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications
• Effective verbal and written communication skills
• Ability to generate, verify, and maintain accurate records
• Analytical skills, attention to detail, and good interpersonal skills
• Demonstrated leadership abilities and coaching for subordinate team members; demonstrated ability to influence without authority
• Ability to organize, judge priorities, and escalate when applicable
• Strong emphasis and understanding of a formalized medical device Quality Management System

Preferred Skills and Competencies

To excel in this role, you should have:

• Direct experience of 5 or more years in writing and filing global vigilance reports within the medical device industry
• Experience in dealing directly with regulatory bodies
• BSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator
• Working knowledge and application of ISO 13485 and FDA 21 CFR Part 803 & 820 quality system requirements and other applicable regulations

Work Environment and Company Culture

Insulet Corporation offers a state-of-the-art and comfortable workspace, even in a remote setting. As a remote/flexible professional, you will enjoy the flexibility to work from home or a hybrid on-site/virtual arrangement. Our company culture values innovation, teamwork, and customer satisfaction.

Compensation, Perks, and Benefits

The US base salary range for this full-time position is $101,500.00 - $152,500.00. Our salary ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. We also offer a comprehensive benefits package, including bonus, equity, and other perks.

Career Growth Opportunities and Learning Benefits

At Insulet Corporation, we are committed to helping our employees grow and develop their skills. As a Manager, Global Vigilance Writing, you will have opportunities to lead special projects, participate in internal and external audits and inspections, and contribute to the development of quality assurance methodologies and systems.

Conclusion

If you are a motivated and performance-driven individual with a passion for quality assurance and regulatory compliance, we encourage you to apply for this exciting opportunity. As a Manager, Global Vigilance Writing, you will play a critical role in driving the success of our company and improving the lives of patients worldwide. Don't hesitate to apply - we value a great attitude and a willingness to learn above all.

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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