CMC Regulatory Affairs Associate

Responsibilities

• File necessary applications and handle government interactions related to product regulation.
• Author and submit PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
• Review and approve engineering and validation study protocols and reports.
• Review and approve manufacturing changes for Class III implantable medical devices.

Requirements

• CMC background in completing clinical submissions IND/IMPD.
• Experience with manufacturing batch records.
• Early Phase CMC knowledge is a plus.
• French/English speaking ability is a plus.

Recent Experience

• 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.

Education & Experience

• Requires an advanced degree.
• 3 to 5 years of direct experience in the field.