Job Summary : Perform authoring, coordination, and preparation of document packages for regulatory submissions, internal audits, and inspections, with a focus on post-market change regulatory assessments.

Job Requirements :

• BSc in Regulatory; Master's degree a plus
• Minimum 5 years of experience
• Post-market change regulatory assessment experience
• 30-day PMA and annual report memo authoring experience
• Experience with RTR submissions and site transfer submissions

Preferred Skills :

Ability to collaborate cross-functionally to complete change management activities

Job Responsibilities :

• Author, coordinate, and prepare document packages for regulatory submissions from all areas of the company
• Lead or compile all materials required in submissions, license renewal, and annual registrations
• Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
• Monitor and improve tracking / control systems
• Keep abreast of regulatory procedures and changes
• Direct interaction with regulatory agencies on defined matters
• Recommend strategies for earliest possible approvals of clinical trial applications
• Support change management activities with a sense of urgency to provide solid regulatory assessments for changes during the product lifecycle

Pay Details : $38.00 to $51.00 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

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