Regulatory Affairs Manager
Job Description

Partial Job Description

1) Compile domestic and international regulatory submissions for product approvals

2) Interact with regulatory bodies for submissions (medical device or pharma)

3) Manage international regulatory requirements (medical device inspections, inquiries) of ISO 13485, EU

4) Accomplish quality system/GMP requirements (medical device or pharma)

5) Manage labeling requirements (medical device/pharma) directives

6) Oversee technical/scientific methodology and data review for compliance and submissions

7) Review QC product, product complaints/adverse event investigation data
More questions? Want to know the Salary range? Keep reading.

The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling.

Tips:

1) Follow our CEO on Twitter for status-updates about your job application:
http://www.twitter.com/sterlinghoffman

2) Add our CEO on Facebook:
www.facebook.com/angel.mehta99

We will try to respond to your questions privately via Twitter or Facebook only.

TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Healthcare, Life Sciences, Scientist, R&D, Clinical Research, Clinical Trial, Regulatory Affairs, Nutraceutical, Surgeon, MD, Hospital, Immunology, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility, Hospital, Research and Development, Medical Affairs, Drug Safety



Job Requirements

Qualifications / Skills Required

1) Advance degree in sciences (MS, PhD) preferred

2) Education and experience in release/shelf-life data

3) Minimum 4 - 10 years of related experience and/or training or equivalent combination of education

4) Supervisory experience

5) Background in a scientific discipline along with experience

6) Problem-solver

7) Proven team management skills

8) Demonstrated communication (written/oral) skills

9) Dispute resolution skills

Company Overview

Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.


  • Apply Now
  • Regulatory Affairs Manager @ Sterling Life Sciences

Almost there!

Submit your email address to begin the application process for the Regulatory Affairs Manager job. .

Email is invalid Email address is needed

By applying to a job using CareerBuilder.com you are agreeing to comply with and be subject to the CareerBuilder.com Terms and Conditions for use of our website.