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Head of Regulatory Affairs

Company: Sterling Life Sciences
Location: Sterling
Posted on: September 12, 2020

Job Description:

Sterling-Hoffman Executive Search Located in: Virginia

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

1) Prepare and maintain regulatory submissions and registrations of devices

2) Prepare and maintain annual renewals of establishment registrations, device listing and other pertinent regulatory licenses

3) Review customer complaints to determine regulatory report ability requirements

4) Participate in the evaluation of changes to the QMS documents and device design for impact on pending and existing registrations

5) Review complex reports and validations for scientific merit and regulatory appropriateness

6) Provide technical review of data and reports that will be incorporated into regulatory submissions to ensure scientific rigor, accuracy and clarity of presentation

7) Advise project teams on premarket regulatory and labeling requirements and clinical study compliance issues

8) Monitor and advise the Senior Quality Technician for upcoming and new guidance, regulations, agency and industry initiatives to ensure regulatory strategies are in alignment with company objectives

9) Interpret regulatory rules and changes and ensure that they are communicated through corporate policies and procedures

10) Participate in compliance activities related to department and company, when needed

11) Work closely with Regulatory Affairs, R&D, Quality, Manufacturing and Marketing teams

12) Apply business and RA ethical standards

13) Perform due diligence

14) Assess and interpret regulatory requirements and their impact

15) Work with cross-functional international teams

16) 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 management

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

Keywords: Sterling Life Sciences, Sterling , Head of Regulatory Affairs, Other , Sterling, Virginia

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