Regulatory Affairs Manager
Job Description

If you are looking to work with a well-established company - one of the top names in the industry - you should not let this opportunity pass by. However, for this Regulatory Affairs Manager role, you must be someone who is experienced and passionate about regulatory affairs management.


1) Manage all regulatory affairs activities in support of medical device product development, including clinical, preclinical and marketing issues

2) Provide support for the Regulatory Department to ensure efficient and compliant business processes and environment

3) Develop regulatory pathways, which can ensure successful regulatory submissions

4) Maintain up-to-date knowledge of laws, regulations and policies enforced by the federal and state governments

5) Participate on product development teams to ensure international regulatory requirements are incorporated as part of the development process

6) Co-ordinate the development of regulatory strategies for investigational, new or modified products

7) Monitor global regulatory trend and requirement impacting the development and commercialization of products

8) Maintain regulatory filings and compile all documentation needed for annual reporting and approval supplements

9) Work with cross-functional personnel in research and development and clinical affairs

10) Ensure compliance with all applicable U.S. and international regulatory requirements


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

1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the medical device industry is strongly preferred
4) Preference will be given to people have recent experience in regulatory affairs management

If you believe you have the ability to excel in this role, this could be the right opportunity to work with a great company in the medical device industry.


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.


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  • Regulatory Affairs Manager @ Sterling Life Sciences

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