Job Description

Job Description

R&D Partners is seeking to hire a Global Regulatory Affairs Manager in Orange County .

Your main responsibilities as a Global Regulatory Affairs Manager :

• Independently provide tactical and strategic leadership on complex projects by actively contributing to the development and implementation of global regulatory strategies throughout the lifecycle of medical devices
• Oversee global regulatory strategy development, planning, and implementation for multiple complex programs and platforms
• Interpret, apply and implement global regulations to projects and prepare regulatory submissions, particularly those in the US, EU, and Canada
• Identify and manage resolution to routine and complex issues including regulatory risk and provide risk/benefit strategies
• Actively participate in project team meetings and provide leadership in meeting submission goals

What we are looking for in a Global Regulatory Affairs Manager :

• Bachelor s required in related scientific discipline with a minimum of 5 years of regulatory experience and demonstrated leadership on complex regulatory strategies and projects
• Experience in a medical device manufacturing facility/development laboratory preferred
• Requires change assessment and submission experience for US and EU (STeDs, 510(k)s, and PMAs)
• Experience with change assessment and submission for Canada preferred
• Risk identification and problem solving skills

Why Choose R&D Partners ?
As an employee, you have access to a comprehensive benefits package including:

• Medical insurance PPO, HMO & HSA
• Dental & Vision insurance
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Expense reimbursement
• Online timecard approval

Salary:

• $180,000 to $241,000 (Dependent on Experience)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.

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