Senior Regulatory Affairs Specialist

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We are seeking a driven individual with a passion for the medical device industry. One of our clients is looking to add a strong Senior Regulatory Affairs Specialist to their team:

1) Coordinate and prepare product submissions for FDA and other major market regulatory agencies
2) Assist in the preparation of periodic reports for FDA and other major market regulatory agencies as required by product status
3) Develop and create regulatory strategies to ensure business goals are met
4) Interface with governmental agency on projects/products as identified by the manager
5) Negotiate directly with FDA at the reviewer level as directed by the manager
6) Review and evaluate promotion and advertising material for compliance with regulations
7) Provide regulatory direction to development project teams as a core team member and develop regulatory strategy for new products
8) Evaluate risk of proposed regulatory strategies and offer solutions
9) Manage the process of writing package inserts


  • 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 senior regulatory affairs

    Our client provides employees with a supportive environment that fosters growth and success. If you share their passion, they welcome your application for consideration!


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: 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


Seniority Level:
Experienced - Not Management
  Regulatory Affairs
Preferred Industry Background:
Managing a team of:
Required Travel:

Base Salary:
Other Compensation: