Senior Regulatory Project Manager

Amotec is actively recruiting for a Sr. Regulatory Project Manager in Clearwater, FL as well as other locations. Reporting to the Regulatory Affairs Manager, the Senior Regulatory Project Manager will be responsible for leading Regulatory Affairs projects as part of the company global product lines of medical devices. Additionally, they will oversee the regulatory team through all phases of the project to aid in regulatory filings. This position offers a competitive base salary, bonus opportunities and opportunity for future advancement.

Other Senior Regulatory Project Manager Responsibilities include:

• Lead post approval submission amendments and yearly reporting for regulatory compliance
• Supplying regulatory advice and updates to both internal and external stakeholders
• Provide strategic project management insights on short and long term global regulatory projects
• Develop new systems to continuously improve and drive change

Qualifications:

• Must have medical device experience and knowledge (Class 1 and/or Class 2 a plus)
• Proven ability to lead complex projects in a cross functional team environment
• Bachelor's Degree with 3-5 years of regulatory experience or Master's degree/PhD with 2-3 years of regulatory experience

If you are interested, please reach out to David Cremi at (216) 535-2710 ext. 5232 or email at [email protected] for more information.