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Regulatory Affairs Associate

Company: Kelly
Location: Deerfield Beach
Posted on: October 18, 2020

Job Description:

Title:  Regulatory Affairs Associate

Location:  Deerfield, IL 60015

Duration:  6 months contract; Contract to hire for the right candidate

Compensation:  Up to $36.66 per hour; depending on experience

Summary

This role is responsible for providing regulatory support for products on the market or intended to be launched into markets. Activities include data management, change assessment, variation plan delivery, creation of data submission documentation, process and product support, and participation in project sub-teams.

Responsibilities

• Responsible for coordinating the collection and maintenance of all required xUDID (e.g., Master Product Content) data from identified sources within the core and extended design team, routing data source and xUDID Data to SME for approval, ensuring required compliance and timelines are met.

• Acts as the Business Analyst for the xUDID Information & Data workflow tool (PIM & BaxSolid) under the direction of the xUDID Manager

• EUDAMED and UDID SME role to revise or add modifications to data and data systems to manage data compliance to global regulations.

• Responsible for working with other parts of the regulatory organization to achieve desired results

• Develop and execute global plans and regulatory submission deliverables for sustaining variations

• Support special projects as needed

• Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results

• Interpret and apply emerging regulatory requirements to ongoing work

• Ensure identified standards and content requirements are met for regulatory submissions

• Timely, actively support query responses

• Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements

• Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s).

• Maintain regulatory files in a format consistent with requirements

• Track status, quality/compliance and progress of regulatory documentation and xUDID SharePoint management.

• Review and proofread regulatory documentation

Qualifications

• Familiarity with EUDAMED, UDID or similar regulated data management systems, processes and requirements.

• Experience operating in a regulated environment

• Ability to operate in a matrixed-environment and manage multiple activities, priorities and deadlines

• Project management (preferred)

• Exercise independent judgement

• Scientific knowledge and ability to discuss technical matters with cross-functional team members

• Knowledge of regulations and ability to communicate and apply

• Ability to identify compliance risks and escalate when necessary

• Demonstrated leadership, coaching or mentoring skills

• Excellent verbal and written English communication skills, suitable for multi-location working relationships

• Demonstrated teamwork and collaboration skills

• Aptitude for Attention to Detail

Education / Experience

• Minimum Bachelor’s degree will be required

• Bachelor’s Degree or country equivalent in related scientific, IT or business systems discipline

• Associate or Equivalent - Minimum of 1-year regulatory experience in RA or related healthcare environment

• Project management experience (nice to have)

• Software: Database (nice to have); Microsoft Word, Excel, Outlook, PowerPoint, SharePoint, and Access (nice to have)

Why Kelly ® ?

As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

About Kelly ®

At Kelly , we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

#KellyGTS

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Keywords: Kelly, Deerfield Beach , Regulatory Affairs Associate, Other , Deerfield Beach, Florida

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