Manager of Quality and Regulatory Affairs

Sterling-Hoffman Executive Search Located in: Delaware
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If you're someone who is game for a challenge and has the QA/RA Management experience our client is looking for, this could be best opportunity out there for you! Read on...

1) Implement, manage and sustain division-wide quality assurance program to ensure conformity with US FDA, EU, ISO, CMDCAS, JPAL and other applicable quality and regulatory requirements
2) Manage/lead an overall quality system and drive successful continuous improvement efforts
3) Develop, implement and maintain corporate quality standards, policies, procedures, and processes
4) Interface with external regulatory bodies as required in response to communications received, as well as facilitate required external inspections or audits
5) Ensure that all applicable regulatory filings are made and approvals are obtained prior to product beings shipped from the division
6) Identify and implement continuous quality system improvements
7) Provide regular and timely updates to Director of Quality as to the compliance status of the quality system
8) Ensure that all finished products conform to specified requirements and that finished products which do not conform to requirements are prevented from being used or delivered
9) Comply with divisional quality system, training management system - electronic, complaint management and CAPA management
10) Manage internal and external audits, document control - electronic and internal product registrations


  • 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 who have recent experience in QA/RA Management

    This is an amazing opportunity for someone who isn't afraid of rolling up their sleeves to get things done and has a great attitude. Our client believes in adding value to each and every thing they do and are looking for someone with similar values.


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: 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


Seniority Level:
Management / Supervisory
Preferred Industry Background:
Managing a team of:
Required Travel:

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