Regulatory Affairs Associate III

  • location: Deerfield, IL
  • type: Contract
  • salary: $40 - $46.23 per hour
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job description

Regulatory Affairs Associate III

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed!

 
location: Deerfield, Illinois
job type: Contract
salary: $40.00 - 46.23 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • 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 planning, creation of data submission documentation, identification of local data submission requirements, product/facility change management, process support, and participation in project sub-teams.
  • EUDAMED and UDID SME role to interpret regulations and revise or add modifications to data and data systems to manage data compliance to global regulations.
  • Infrastructure Development for Global Emerging UDI Requirements for multiple countries
  • Review and provide global regulatory impact assessments for changes
  • Author and manage global submission deliverables for product variation submissions
  • 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
  • Review, edit and proofread regulatory documentation
 
qualifications:
  • Bachelor's Degree or country equivalent in related scientific or business systems discipline
  • Minimum of 5 years regulatory device experience in RA or related healthcare environment (not pharma)
  • Project management experience
  • Software: Database (nice to have); Microsoft Word, Excel, Outlook, PowerPoint, SharePoint, Access (nice to have) and Project
  • Expertise 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 (recommended)
  • Exercise independent judgment
  • 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
 
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, MS-Project, GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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