Quality/Regulatory Team Leader

We are seeking an experienced professional to fill a gap in regulatory and quality leadership for implantable (Class III) medical devices, including managing submissions and implementing a Quality Management System (QMS).

Job Requirements:

• Proven experience leading the setup and implementation of a Quality Management System (QMS) for medical devices.
• Leadership experience in defining regulatory requirements for medical devices.
• Extensive experience leading regulatory submissions to both FDA and EU-MDR.
• Direct experience with Class III implantable devices, specifically leading the submission process.
• Ability to present quality and regulatory documentation to FDA and EU regulatory bodies.

Preferred Skills:

• Experience with audits, particularly FDA and EU-MDR related.
• Familiarity with preparing for regulatory audits, including upcoming November audits and EU submission deadlines.

Job Responsibilities:

• Lead the implementation of a Quality Management System (QMS) for implantable medical devices.
• Define and manage regulatory requirements for FDA and EU-MDR submissions.
• Prepare and present quality and regulatory documentation to regulatory bodies.
• Oversee upcoming regulatory audits and ensure compliance with submission deadlines for both FDA and EU-MDR.

Pay Details: $40.00 to $60.00 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