Sr Regulatory Operations Specialist - Entegee

Job Summary:
Responsible for managing submission publishing, device listings, UDI data collection, and maintaining regulatory compliance for medical devices in the US and EU markets.

Job Requirements:

• 3-4 years of experience in Regulatory Operations within the medical device industry

• Bachelor's Degree

• Experience with submission publishing, device listings, and UDI data collection and reporting

• Familiarity with QMS updates and providing audit support for FDA, NB, and international agencies

• Experience with RIM systems, Power BI, and Business Objects

• Understanding of US and EU medical device regulations, including submissions, change notifications, and regulatory assessments

Job Responsibilities:

• Lead submission content management and submission publishing for US and EU markets

• Manage regulated master data, including UDI data collection and submission

• Assess new and changing regulations to ensure compliance

• Update regulatory processes and QMS procedures as needed

• Maintain device listings, product licensing, and facility registrations

• Provide audit support for FDA, NB, and international regulatory agency audits

• Collaborate with cross-functional teams to prepare submission content and maintain overall regulatory compliance

Pay: 45-55

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $45.00 to $55.00 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