REMOTE Part Time Sr Regulatory Affairs Specialist

Job Summary:
Responsible for managing regulatory compliance for product modifications and ensuring adherence to US and EU regulatory requirements, with a focus on change control and sustaining the current product portfolio.

Job Requirements:

• 4+ years of experience in regulatory affairs with strong change control experience
• Bachelor's degree
• Expertise in US and EU regulatory requirements for product modifications
• Experience with EU MDR Regulation & Remediation, IDE and PMA submissions, and MDD and MDR STED updates
• Familiarity with MAP Agile, ISO 13485, FDA Medical Devices Part 820, and Good Documentation Practices for medical devices

Job Responsibilities:

• Provide strategic input and technical guidance on regulatory requirements for product modifications
• Manage IDE and PMA Annual Reports, Supplements, MDD and MDR STED updates, and EU MDR submissions
• Review and assess change orders with a focus on US and EU regulatory requirements
• Maintain accurate product technical documentation and review promotional materials
• Collaborate with cross-functional teams, including engineering, quality, and marketing, to ensure regulatory compliance
• Participate in internal and external audits as needed
• Create or revise departmental procedures to align with changing regulatory requirements

Pay Details: $60.00 to $70.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance