Senior Regulatory Affairs Specialist
October 16
Description
• The primary responsibility involves the preparation of regulatory submissions to the FDA. • Assisting with compliance activities related to GMP and ISO regulations. • Interfacing with Regulatory Agencies on assigned projects. • Responding to Regulatory Agencies requests for additional information. • Keeping abreast of changes to worldwide regulatory requirements.
Requirements
• Proficient knowledge of Microsoft Office, Word, Excel, and PowerPoint. • Familiarity with U.S. and foreign country regulatory requirements and submissions. • Excellent verbal and written communication skills, analytical skills, teamwork and interpersonal skills. • Skilled in the conduct of research on the Worldwide Web for regulations, guidelines, standards, medical device information, etc. • Familiarity with Acrobat and AutoCAD. • ISO 9000/QSR experience. • Prior employment with FDA. • Experience in Sleep Apnea Therapy or neuromodulation implantable devices.
Benefits
• Health benefits – Medical, Dental, Vision • Personal and Vacation Time • Retirement & Savings Plan (401K) • Employee Stock Purchase Plan • Training & Education Assistance • Bonus Referral Program • Service Awards • Employee Recognition Program • Flexible Work Schedules
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