Senior Specialist in Regulatory Compliance
2 weeks ago
About Us:
At Laborie Medical Technologies, we are dedicated to enhancing healthcare as a fundamental aspect of human dignity. Our mission is to make a significant difference in the lives of patients worldwide. We are committed to fostering an inclusive environment that promotes career growth and a sense of belonging among our employees.
Position Overview:
We are seeking a Senior Regulatory Affairs Specialist to join our dynamic team. This role is pivotal in providing comprehensive regulatory support for both new product approvals and the renewal of existing products. The specialist will be responsible for developing regulatory requirements and preparing necessary submissions.
Key Responsibilities:
- Drafting documentation for international regulatory submissions.
- Creating technical documentation that adheres to regulatory standards.
- Identifying global regulatory requirements essential for product approval.
- Leading cross-functional teams as the regulatory representative.
- Maintaining regulatory documentation to ensure readiness for external audits.
- Preparing submission packages and managing project timelines.
- Offering guidance and support to team members regarding regulatory compliance.
- Serving as a Subject Matter Expert (SME) during internal and external audits.
- Bachelor's Degree in a relevant field such as Science or Engineering.
- A minimum of 8 years of experience in Regulatory Affairs within the medical device sector.
- Experience with FDA, EU, Health Canada, and international regulatory submissions.
- Familiarity with quality system regulations and guidelines.
- Strong ability to produce clear and concise reports, both written and oral.
- Excellent communication skills across all organizational levels.
- High organizational and planning capabilities.
- Understanding of medical devices, procedures, and terminology.
Our daily mission is to operate as a premier medical technology company, advancing solutions that uphold human dignity. We are committed to supporting individuals with pelvic and gastrointestinal conditions and ensuring safe deliveries for mothers and babies.
Benefits:
- Generous paid time off and volunteer opportunities.
- Comprehensive medical, dental, and vision plans.
- Health Savings Account with company contributions.
- 401k retirement plan with matching contributions.
- Parental leave and adoption support services.
- Health and wellness initiatives and events.
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