Quality Assurance and Regulatory Affairs Director

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JOB DESCRIPTION

A leading company in the medical device industry is currently seeking a Quality Assurance and Regulatory Affairs Director to join their team. The role will be challenging but also highly rewarding and this leader will be a key voice in the company. For the right executive, this is a fantastic opportunity with great growth prospects. Key duties include:

1) Ensure compliance with FDA and other applicable international regulations and requirements for design and development of medical devices
2) Lead all RA-related activities
3) Facilitate external quality system audits and guide the organization during FDA inspections
4) Ensure regulatory compliance of company’s product realization processes
5) Ensure that the national and international medical device and ISO compliance regulations are met
6) Administer and manage all aspects of an effective company’s QMS
7) Lead development and implementation of quality procedures, work instructions and forms
8) Conduct management reviews to monitor the suitability and effectiveness of QMS implementation and applicable regulatory requirements
9) Provide support to the company in designing, development, manufacture and improvement of regulated and non-regulated medical devices
10) Prepare and provide guidance regarding required documentation for domestic and foreign submissions and registrations
11) Lead efforts to ensure timely evaluation of nonconforming products at company’s manufacturing sites
12) Lead the review and approval of site’s corrective action plans for product and process QMS audits
13) Provide support to sales efforts by responding to clients’ questionnaires and requests for proposals

CRITICAL REQUIREMENTS

  • 1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
    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 candidates with recent experience in quality assurance and regulatory affairs management

    If you are qualified and 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 Quality Assurance and Regulatory Affairs Director role, you must be someone who is experienced and passionate about quality assurance and regulatory affairs management.

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:
Director / VP
Function:
  Quality
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: