Global Vigilance Writing Team Lead

The Team Lead, Global Vigilance Writing is a hands-on technical leader serving as a post-market vigilance (reportable event) and surveillance subject matter expert and representative. This role will provide direction to individuals who are responsible for the assessment, follow-up, coding, and vigilance activities for complaints determined to be reportable for the US FDA and other countries. The role requires strong organisation skills, attention to detail while working in cross-functional teams to accomplish departmental and company goals.

Key Responsibilities:

• Mentor and help develop direct reports through yearly/quarterly reviews, weekly meetings, and daily interactions.
• Support a positive culture with clear communication regarding goals and objectives.
• Provide leadership to team members, including but not limited to, training support on process and procedures.
• Provide coaching and feedback in accordance with company SMART goals.
• Establish / Track daily team metrics to ensure performance targets are achieved.
• Approve / Sign-off work of direct reports and other team members.
• Provide input to management to define reports/dashboards to identify delinquency or backlog in all aspects of the surveillance process.
• Manage direct reports to ensure the timely processing of customer complaints and adverse event reports.
• Responsible for the assessment, follow-up, coding, and vigilance activities for complaints determined to be High-Priority for the US FDA and other countries.
• Author, peer review, and approve vigilance reports to ensure on-time submissions to the appropriate regulatory authorities.
• Collaborate with engineering, complaint investigation laboratory, medical and other internal staff as applicable to review events, coding, and investigation results to support regulatory reporting compliance occurs per procedures, standards, and regulations.
• Lead or contribute to departmental non-conformances, events and CAPAs.
• Serve as a subject matter expert for post-market and complaint handling regulatory questions and inquiries.
• Support internal and external audits and inspections.
• Assist with special projects, as assigned, with minimal supervision.
• Perform other duties as required.

Qualifications:

• Bachelor’s degree preferred.
• Relevant experience in medical device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device support or appropriate combination of relevant education and experience preferred.

Preferred Skills and Competencies:

• Proven leadership skills to engage, coach, mentor, and develop the team, inspire high quality and timely work.
• Effective verbal and written communication skills.
• Proven experience to organise, prioritise and follow through on multiple tasks with minimal supervision.
• 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.
• Direct experience in writing and filing global vigilance reports within the medical device industry.
• Experience in dealing directly with regulatory bodies is highly desired.
• BSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator, preferred.
• Strong emphasis and understanding of a formalised medical device Quality Management System.
• Ability to generate, verify, and maintain accurate records.
• Must have analytical skills, be detail oriented, and have good interpersonal skills.
• Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications.

Physical Requirements:

• General office environment – may sit for long periods of time.
• This position requires extensive computer use.