Easter Seals Jobs

Title : Regulatory Affairs Specialist (Senior Level)

Pay : $38-$50/hr depending on experience

Shift : M-F, standard working hours. Hybrid role

Temp to hire

Overview:

We are seeking a Regulatory Affairs Specialist (Senior Level) to ensure company compliance with US FDA 510(k), Health Canada Licensing, International Device Submissions, Licensing and Registration requirements, ISO/FDA QSR, and ISO 13485. The role involves quality system auditing and more specific responsibilities as outlined below.

Responsibilities :

• Lead and Support US 510(k) Submissions

• Lead and Support Health Canada Device License Applications

• Lead and Support International Device Licensing and Registrations

• Support Product Development Teams for New Product Submission Requirements

• Product Technical Files Development and Maintenance

• Review and Approval of ECOs Related to Assigned Projects

• Experience with EU MDD and EU MDR

• Participate in Quality System Audits

• Technical Writing and Documentation

• Support UDI Labeling Projects

• Managing and Driving All Aspects of International Regulatory Affairs from Creation to Submission of Technical Documentation (e.g., Technical Files, Design Dossiers, GSPRs for CE Marking) and Post-Market Follow-Ups

• Support FDA Regulatory Requirements with Creation, Reviewing, Editing, Assembling, and Submission of Documentation (e.g., 510(k)s, Pre-subs, IDEs, PMAs, etc.)

• Oversee Strategy Implementation and Operations for Developing Product Registration Submissions, Progress Reports, Supplements, Amendments, or Periodic Experience Reports

• Interact with Regulatory Agencies to Expedite Submissions and Approvals

• Monitor Regulatory Outcomes of Initial Product Concepts and Provide Input to Senior Regulatory Management

• Collaborate with Clinical Operations to Ensure Clinical Study Results and Reports are Suitable for Regulatory Submissions

• Responsible for Adverse Event (Vigilance, MDR) Reporting and Assessment, Evaluation of Product Complaints, and AE Report Compliance

• Establish and Maintain Procedures Relating to MDR/CE Marking Processes in Accordance with MDCG, ISO, and Other Regulatory Requirements

• Serve as Regulatory Liaison Throughout Product Development Lifecycle

• Participate in Product Plan Development, Regulatory Strategy, Product Labeling, Risk Management, Post-Market Surveillance, and Post-Market Follow-Up

• Ensure Alignment of Regulatory Strategy to Business Strategy Across All Functional Areas

• Serve as a Regulatory Representative to Marketing, Clinical, Research Teams, and Regulatory Agencies

• Ensure Regulatory Submissions and Technical Documentation Meet Standards and Content Requirements

• Advise Development and/or Marketing Teams on Product Changes, Line Extensions, Technical Labeling, Regulations, and Interpretations

• Write Regulatory Justifications to Support Design Changes and Submission Filing Decisions

Requirements:

• Bachelor’s degree

• 5+ years of experience with EU MDD and EU MDR

• 5+ years of experience with 510(k) submissions

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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.