Regulatory Affairs Specialist Jobs

About The Position

Requirements

• Bachelor's degree.
• At least 5 years of regulatory affairs experience, preferably in the medical device industry.
• Proven experience with electro-mechanical products.
• Experience building regulatory strategies to support a successful regulatory affairs team.
• Proven written and verbal communication skills for interfacing with a variety of stakeholders.
• Ability to create action plans and project deliverables.

Nice To Haves

• Advanced degree.
• Regulatory Affairs Certification.
• Experience in the electrocardiology, defibrillation, or respiratory space.

Responsibilities

• Develop and implement regional regulatory strategies for new and sustaining products and features to achieve device approval.
• Keep project team colleagues, line management, and key stakeholders informed of developments that may affect regulatory success, using sound judgment and timely, professional communication.
• Provide a regional regulatory perspective during the development, review, and approval of internal and external documentation supporting product development and commercialization.
• Work with regional regulatory affairs and product teams to ensure regulatory requirements are considered and accounted for in programs and projects.
• Author and prepare submissions, including IDEs, 510(k)s, PMAs, Technical Files or Design Dossiers, and other applicable regional device applications.
• Work with management on risk assessment and regulatory compliance.
• Support cross-functional NPI project teams and provide regulatory guidance.
• Maintain current knowledge of regulations and guidance; collaborate with product teams on approvals, share information, and develop potential strategies.
• Lead, support, and coordinate internal and external resources to meet audit and compliance requirements.
• Promote best practices and innovation, recognize achievements, and report on KPIs to track continuous-improvement progress and impact.
• Support team members in preparing suitable written responses to regulatory inquiries.

Benefits

• Annual bonus in accordance with the company's bonus plan.
• Comprehensive benefits plans.