Regulatory Affairs Associate

• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
• Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing changes for Class III implantable medical devices.
• May require an advanced degree and 3 to 5 years of direct experience in the field.
• Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.
• Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks.
• May lead and direct the work of others. A wide degree of creativity and latitude is expected

Required Experience:

• 6 years pharmaceutical or industry related experience.
• 3-5 years in quality systems or cross-functional project management

Preferred Experience:

• 6 years pharmaceutical experience including 5 years in regulatory affairs or 5 years in Discovery, R&D, or Manufacturing
• Experience working in a complex and matrix environment
• Strong oral and written communication skills
• This contractor will work with internal and external partners in order to deliver products to patients.
• Prepare regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision and responds to regulatory information.
• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions
• Manages preparation for agency meetings and manages content of pre-meeting submissions.
• Manages products and change control with an understanding of regulations and company policies and procedures.

Required Education:

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.