REGULATORY AFFAIRS SPECIALIST III – IV

Regulatory Affairs Specialist

Would you like to work for an innovative company? If so, come join our team!

Description of Position Responsibilities:

• Prepare hardcopy and electronic information packages for submission to regulatory agencies.
• Participate on product development core teams as regulatory representative.
• Create regulatory strategies for domestic and international markets.
• Monitor and receive deliverables for submissions.
• Write and/or edit submission documents using regulatory templates.
• Assemble paper and/or electronic copies for submission.
• Assess manufacturing process and labeling changes for regulatory reporting impact.
• Keep informed of new and revised regulations; disseminate information as directed by management.
• Interact with regulatory agencies.
• Prepare internal procedures for continuous process improvement.

Excellent Salary

Benefits include:
401k, Stock Options, Medical / Dental Insurance, Vacation and Sick Time.

Related Business / Technical Skills, Knowledge, Abilities:

• Solid computer skills.
• Solid written and oral communication.
• In vitro diagnostics submission experience, US and International.

Education and Experience Requirements:

• Typically requires a BS / BA degree or equivalent and a minimum of 2 – 5 years related experience or MS degree or equivalent and 1 – 3 years related experience.

For immediate consideration, please forward a copy of your current resume to info@profrecruiters.com referencing job # or a link to this job.

Job & Company Detail