Senior Principal Regulatory Affairs Specialist

A highly respected company in the Life Science industry is looking to bring on a Sr Principal Regulatory Affairs Specialist to oversee a team within the organization. This person will develop, maintain, and monitor policies, procedures, practices, and activities to assure compliance with all FDA standards. This position offers an excellent benefits package; apply now!

Sr Principal Regulatory Affairs Specialist Responsibilities:

• Lead the regulatory clinical efforts, including establishing and maintaining clinical protocols, informed consent, IRB submissions, trial monitoring, data preservation, and record keeping.
• Maintain close liaison with regulatory authorities (domestic and foreign) and clinical, scientific, and manufacturing collaborators on matters that impact the regulatory responsibilities of the company.
• Audit and monitor internal processes and contract facilities for compliance with regulatory requirements, including FDA, CE, and ISO in application to medical devices.
• Participate in the product development process to assure products are designed in compliance with FDA regulations and applicable international quality systems standards.
• Within the management team, propose, develop and implement regulatory policies and strategies.
• Design, develop, and deliver regulatory training to employees.

Sr Principal Regulatory Affairs Specialist Requirements:

• 15+ years’ regulatory experience required – advanced degree preferred
• Proven ability to lead, establish, maintain and influence effective working relationships with internal customers within the region and across functions.
• Strong influencing ability and ability to provide functional supervision to the regulatory team as required.
• Self-motivated, ambitious, and able to manage multiple people
• Strong work ethic, problem-solving skills, and leadership abilities
• Attention to detail and organizational skills a must

Sr Principal Regulatory Affairs Specialist Benefits:

• Excellent benefits package including healthcare, dental, vision, vacation, and 401k

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 30 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 31 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.

SDL2017