Regulatory Affairs Associate

Katalyst-Healthcares-; North Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

Fives DyAG Corp. seeks an experienced regulatory affairs professional to manage government interactions and regulatory submissions for Class III implantable devices.

The role focuses on PMA supplements, annual reports, and change control, ensuring compliance with FDA CFR guidance. The candidate will review complex study protocols, lead cross-functional teams, and coordinate with internal and external partners to deliver regulatory-ready documentation for patients requiring advanced medical

Qualifications

• 6 years pharmaceutical or industry related experience.
• 3-5 years in quality systems or cross-functional project management.
• Experience preparing regulatory submissions and amendments.

Responsibilities

• Filing applications and handling government interactions for regulatory approvals.
• Authoring and submitting PMA supplements and annual reports.
• Review/approval of engineering study protocols and validation reports.
• Review and approval of manufacturing changes for Class III devices.
• May lead and direct the work of others; high level of judgment required.
• Prepare regulatory submissions and respond to regulatory information requests.

Skills

Regulatory affairs

PMA submissions

Quality systems

Cross-functional

Regulatory strategy

Education

Bachelor's degree in related field

Job description

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.