Global Regulatory Affairs Specialist

Sotera Health Company; Oak Brook (IL); In loco; USD 63.000 - 95.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, Dental, Vision Insurance

401(k) with Company match

Paid holidays, vacation, and sick time

Education assistance

Descrizione del lavoro

Sotera Health Company in Oak Brook is seeking a Regulatory Affairs Specialist to support regulatory strategy, prepare listings, and ensure compliance. Ideal candidates will have a bachelor’s degree in Life Sciences or Engineering and at least two years of experience in regulatory affairs.

This role includes managing FDA annual updates, training Customer Service staff, and acting as a subject matter expert in regulatory registrations. Competitive pay and a comprehensive benefits package are offered.

Competenze

• 2 years of related regulatory affairs experience in Medical Device, Pharmaceuticals, Tissue or Food.
• Experience with FDA and other government regulations.

Mansioni

• Support regulatory strategy, certifications, and compliance.
• Manage FDA annual update process and GDUFA requirements.
• Provide training to new Customer Service staff.
• Act as the subject matter expert for regulatory registrations.

Conoscenze

Detail oriented

Regulatory knowledge (FDA, ISO 13485)

Understanding of FSMA requirements

PCQI/FDQI certification

CAPA and controlled document change experience

Formazione

Bachelor's degree in Life Sciences, Engineering, or related field

Strumenti

FDA registration systems (FURLS, CDERDirect)

Descrizione del lavoro

Sotera Health Company in Oak Brook is seeking a Regulatory Affairs Specialist to support regulatory strategy, prepare listings, and ensure compliance. Ideal candidates will have a bachelor’s degree in Life Sciences or Engineering and at least two years of experience in regulatory affairs.

This role includes managing FDA annual updates, training Customer Service staff, and acting as a subject matter expert in regulatory registrations. Competitive pay and a comprehensive benefits package are offered.