Regulatory Affairs Associate II

Required Education

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

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

Job Deliverables

• Prepare regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision.
• Responds to regulatory information.
• Analyzes and interprets information that impacts regulatory decisions.
• Sets up and manages preparation for agency meetings.
• Manages products and change control with an understanding of regulations and company policies and procedures.
• 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.

Skills

• Strong oral and written communication skills

Pay

Target PR Range: 29-39/hr Depending on experience

Schedule

Not specified

Benefits

Not specified

Qualifications

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.

Skills

• 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