Regulatory Affairs Associate

Katalyst CRO; North Chicago (IL); Presencial; USD 120 000 - 160 000; Tempo integral

Resumo da oferta

Katalyst CRO in North Chicago seeks an experienced Regulatory Affairs Specialist contractor to oversee government filings for complex Class III implantable devices. You will lead PMA-related submissions and ensure CFR compliance across programs, collaborating with engineering, QA, and manufacturing teams.

The role requires 3–5 years of direct regulatory experience, strong document authoring, and a proven track record in PMA approvals.

Qualificações

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, or engineering.
• Experience filing PMA supplements and regulatory submissions.
• Knowledge of FDA PMA guidance documents and CFR regulations.
• 3-5 years in quality systems or cross-functional PM.
• Strong communication with internal and external partners.

Responsabilidades

• File applications and manage government interactions for regulatory approval.
• Author PMA supplements and related notices.
• Review engineering study protocols and validation reports.
• Review and approve changes for Class III implantable devices.
• Lead and mentor regulatory team members as needed.
• Coordinate with partners to deliver regulatory submissions.
• Prepare agency meetings and pre-meeting submissions.
• Manage change control in line with regulations.

Conhecimentos

Regulatory affairs

PMA submissions

FDA CFR knowledge

Quality systems

Project management

Communication skills

Formação académica

Bachelor's degree in pharmacy

Regulatory affairs certification

Descrição da oferta de emprego

• 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

Responsibilities

• 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.