Senior Manager of Regulatory Affairs

Sterling-Hoffman Executive Search Located in: Portland, OR,  Oregon
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Our client, a supplier of surgical and other medical instruments, is looking for a Senior Manager of Regulatory Affairs with solid Regulatory Affairs experience. Specifically, we are seeking an individual who is able to handle the following responsibilities:

1) Prepare and manage all regulatory documents for international registrations and tenders on a timely basis
2) Ensure all protocols and data collection meet agency’s needs
3) Manage and review performance data provided by the company
4) Conduct labeling and label reviews, as required
5) Participate in design transfer, as required
6) Manage and prepare e-submissions with complete documentation and appropriate forms
7) Collaborate and coordinate with the Marketing Department to determine future submission requirements and develop regulatory plans
8) Maintain current registration documentation
9) Maintain proper logs, contacts and processes for authentication of registration documents
10) Develop regulatory plans and strategies
11) Create and maintain product design and technical files
12) Perform other duties as assigned


  • 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 instruments industry is strongly preferred
    4) Preference will be given to candidates with recent experience in regulatory affairs

    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!


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:
Management / Supervisory
  Regulatory Affairs
Preferred Industry Background:
Managing a team of:
Required Travel:

Base Salary:
Other Compensation: