Senior Specialist, Regulatory Affairs

Responsibilities

• Develop and deploy regional regulatory strategies for product approvals
• Communicate regulatory developments clearly and timely to stakeholders
• Offer regional regulatory insights for product documentation and commercialization
• Collaborate with teams to ensure regulatory standards are met
• Draft and submit IDEs, 510(k)s, PMAs, and other device applications
• Assist in risk assessments and ensuring regulatory compliance
• Guide cross-functional project teams on regulatory matters

Qualifications

• Bachelor's Degree required; advanced degree preferred
• 5+ years of regulatory affairs experience, especially in the medical device sector, required
• Prominent experience with electro-mechanical products is crucial
• Regulatory Affairs Certification preferred
• Familiarity with electro cardiology or defibrillation/respiratory devices is a plus

Benefits

• Eligible for annual bonus based on company plan
• Open to hybrid or remote working arrangements
• Ongoing application acceptance until position filled