Vice President of Quality and Regulatory Operations

Sterling-Hoffman Executive Search Located in: Tennessee
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JOB DESCRIPTION

A leading company in the medical device industry is currently seeking an accomplished and highly skilled Vice President of Quality and Regulatory Operations to take their company to incredible heights of success. 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) Oversee the development, implementation, testing, compliance of Quality SOPs including development of systems and training of staff
2) Provide effective leadership support, training and guidance to company personnel, manage budgets and schedule resources to effectively meet and anticipate quality and regulatory requirements
3) Ensure quality assurance policies and procedures in accordance with regulatory requirements
4) Develop quality performance measures (KPIs) and provide regular management reports
5) Review company and contractor activities to ensure regulatory compliance
6) Perform inspection of internal and external sites as needed
7) Ensure compliance with “labeling” regulation requirements pertaining to medical devices and tissue including reviewing or coordinating the review and approval of posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers and packaging and other promotional materials
8) Lead the investigation of product complaints and coordinate to ensure a timely and appropriate the response to internal management, customer and regulatory agencies
9) Evaluate impact and analyze regulatory development trends
10) Coordinate with external regulatory counsel, regulatory investigators, external consultants, manufacturers and consultants and the company’s internal departments to ensure compliance and coordinate the successful execution of the company’s regulatory affairs strategies
11) Collaborate with the company’s product development, marketing, customer service, legal, regulatory and manufacturing departments to coordinate the successful ongoing development, training and execution of the company’s Quality System
12) Participate in the developing and implementing of strategies and oversee regulatory filings for marketed products
13) Use regulatory knowledge and experience and advise management about medical device and drug development program strategies to ensure acceptance and earliest possible approval of applications and filings
14) Coordinate and participate in the preparation of regulatory document packages and responses to regulatory agencies, including preparing and reviewing scientific technical documents for regulatory adequacy and compliance to ensure timely preparation and submission of documents, responses and filings
15) Ensure that the company’s internal documentation and tracking/control of regulatory submissions is accurate, up-to-date and in compliance with regulatory requirements

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 and regulatory

    For the right leader, this role is a fantastic opportunity to be a key player in the exceptional success of this renowned company. If you are qualified and think this could be you, please apply ASAP!

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:
  Clinical Research / Affairs,  Manufacturing,  Engineering
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: