Director of Regulatory Compliance

Sterling-Hoffman Executive Search Located in: Tennessee
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JOB DESCRIPTION

A leading company in the medical device industry is currently seeking a Director of Regulatory Compliance 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) Review test protocols and test reports to confirm updated designs and corresponding testing
2) Recommend changes to company procedures in response to changes in regulations and standards
3) Write and update work instructions and policies
4) Analyze product and field complaints and make recommendations regarding their reportability
5) Draft key regulatory submissions and ensure their successful clearance and approval
6) Develop and implement robust regulatory strategies to ensure timely product approvals, registrations and licensing
7) Support development of timely strategies for new product introduction approvals
8) Identify regulatory resource needs to ensure sufficient support for project deliverables
9) Provide regulatory input and set clear requirements for analytical studies in support of assay development
10) Perform other duties as assigned

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 regulatory compliance management

    This position is critical to the team and requires a talent who is both driven and highly skilled. We are looking for real go-getters here, so if you are both qualified and ready to make an impact, 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:
  Quality,  Compliance
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: