Senior Regulatory Affairs Specialist

Sterling-Hoffman Executive Search Located in: Florida
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JOB DESCRIPTION

A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Senior Regulatory Affairs Specialist role. Our client, a leading medical device company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you. Responsibilities include:

1) Manage regulatory submissions and interact with regulatory agencies
2) Provide leadership and submission strategies in the preparation and filing of CMC sections
3) Participate in cross-functional project teams
4) Support customer filing strategies and manage regulatory activities and timelines
5) Oversee investigational and commercialized products
6) Provide CMC regulatory guidance to the Global Regulatory Team
7) Participate and manage post-approval product activities
8) Comply with ISO regulations and standards
9) Provide timely responses to agency submission questions from regulatory agencies
10) Comply with company's policies and procedures
11) 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 affairs

    If you are qualified and this seems like just the right opportunity to take your career to the next level, please apply – we want to hear from you!

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: