Sr Principal Regulatory Affairs Specialist job Minneapolis Minnesota
Sr Principal Regulatory Affairs Specialist job Minneapolis Minnesota
My Spider Scam Awareness Contacting Us F. A. Q.
 
Job Seekers
Search Jobs
Browse Jobs
Post a Resume
Job Alerts
 
Employers
Search Resumes
Browse Resumes
Post a Job

Sr Principal Regulatory Affairs Specialist Job



Employer Name: SpiderID: 10227618
Location: Minneapolis, Minnesota Date Posted: 3/12/2021
Wage: Negotiable Category: Medical/Health
Job Code: M3M - SrPrinRegAffSp

Job Description:

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 compensation and 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 Compensation:



  • $1100,000-$140,000+ DOE

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


You can email me directly at: miki.miller@gogpac.com



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.



Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:


Contact Information:
Contact Name: GPAC Company Type:
Company: GPAC
City:
State:
Zip:

Send ad to a friend


    





© 2021 Job Spider
Privacy Policy | CC Marketing Sites | Site Map | Links