Senior Regulatory Affairs Specialist

Sterling-Hoffman Executive Search Located in: Florida
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JOB DESCRIPTION

Our client, a leading medical device company, is currently seeking an accomplished Senior Regulatory Affairs Specialist to join the team. Here is an overview of the role:

1) Collaborate with cross-functional teams to support customer filing strategies
2) Manage regulatory activities and timelines for products
3) Coordinate the timely compilation and critical review of the CMC data package with other functional teams' representatives
4) Provide CMC regulatory guidance to Project and Global Regulatory teams
5) Serve as the Regulatory Affairs Representative on assigned New Product Development teams and related technical task forces
6) Provide leadership from rapidly modified strategies to unanticipated changes
7) Work with functional experts to provide timely responses to regulatory agencies' submission questions
8) Provide leadership and submission strategies in the preparation and filing of CMC sections of regulatory submissions
9) Manage post-approval products' activities
10) Liaise, negotiate and interact with FDA and worldwide regulatory agencies

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 affairs

    This role is a great opportunity for the right person looking to advance their career with a wonderful company. If you are qualified and think that you are a strong fit for this role, 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:
Experienced - Not Management
Function:
  Regulatory Affairs
Preferred Industry Background:
 
Managing a team of:
N/A
Required Travel:

Base Salary:
Confidential
Bonus:
Benefits:
Other Compensation: