Senior Specialist in Regulatory Compliance
2 weeks ago
Become a vital member of our esteemed organization recognized for its commitment to quality and innovation within the medical device sector. In the role of Senior Specialist in Regulatory Compliance, you will be instrumental in guaranteeing adherence to global regulatory standards for Neurovascular and Peripheral medical devices. Your key duties will encompass the formulation and execution of regulatory strategies, overseeing design control processes, and managing submissions across various regions.
Core Responsibilities:
- Engage with Research & Development and Manufacturing teams on design control initiatives
- Create comprehensive global regulatory strategies for diverse projects
- Oversee submission processes and liaise with regulatory bodies
- Evaluate and uphold regulatory documentation and records
- Facilitate training on regulatory procedures and contribute to enhancements in processes
Qualifications:
- Bachelor's degree in a relevant discipline
- 7-10 years of experience in regulatory affairs
- Proficient technical writing skills with experience in FDA submissions, CE Mark applications, and Health Canada submissions
- Experience in engaging with regulatory authorities
- Meticulous attention to detail coupled with outstanding communication abilities
Desirable Qualifications:
- Advanced degree in a pertinent field
- Experience with active implantable devices and software validation processes
- Robust technical and analytical skills
Compensation:
$92,341 - $138,972 (Salary is determined by education, experience, and skills)
Employee Benefits:
- 15 days of Paid Time Off, Paid Holidays, and a Winter Break
- Tuition Reimbursement opportunities
- Flexible Work Schedule options
- Commitment to Diversity, Equity & Inclusion initiatives
- Access to Learning & Development Programs
We are an equal opportunity employer dedicated to fostering a diverse and inclusive workplace.
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