Regulatory Affairs Manager

Sterling-Hoffman Executive Search Located in: Providence,  Rhode Island
(Private and Secure - Guaranteed!)

Sterling-Hoffman Executive Search Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Partial Job Description 1) Provide regulatory guidance 2) Generate documentation to support and execute RA plans 3) Work closely with the Manufacturing, Scientific and Quality personnel 4) Write, review and edit regulatory documents 5) Participate in discussions with FDA and/or health authorities 6) Review and approve product changes in accordance with regulatory guidelines

CRITICAL REQUIREMENTS

  • Qualifications / Skills Required

    1) University degree

    2) Experience with ISO audits

    3) Ability to act as a liaison to FDA investigators, ISO Auditors, Narragansett Bay Commission

    4) Minimum 5+ years of experience in a similar role in the medical device industry

    5) FDA knowledge and experience

    6) Local to Rhode Island

COMPANY INFORMATION

Sterling-Hoffman is a retained executive search firm that specializes in representing life sciences and technology companies in matters of high impact talent acquisition. Our clients include market leaders and venture capital-backed startups in industries such as: medical device, biotechnology, pharmaceuticals, enterprise software, clinical research, and laboratory services. You may view more of our jobs here: http://www.sterlinglifesciences.com Your privacy is important to us: we will never share your resume without your permission. Please note that only qualified applicants will receive a response. We encourage you to apply for as many jobs as you believe you are a fit for, but strongly suggest that you include your salary information as job seekers who provide salary information are likely to be reviewed sooner. ===================== TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Biotechnology Recruiter, Pharmaceutical Recruiter, Medical Device Recruiter, Biotechnology Career, Clinical Research Job, Regulatory Affairs Job, R&D / Scientist Job, Product Manager Job, Medical Device Sales Job, Biotechnology Sales Job, Quality Assurance Job, Engineering Job, Laboratory Jobs, Microbiology Jobs, CEO Jobs, Marketing Jobs, Manufacturing Jobs, Oncology Jobs, Cardiology Jobs, Hematology Jobs, Medical Jobs

JOB INFORMATION

Seniority Level:
Management / Supervisory
Function:
  Regulatory Affairs
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation:
A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.