Overview
DivIHN (pronounced Divine) is a nationally-recognized Business Technology Solutions and Staffing services provider headquartered in Chicago. Since our formation in 2002, we have been trusted by Fortune 500 organizations to help them locate and hire best-in-class talent through our Award-winning Professional Workforce Solutions program.
Check out our careers page to see all of our job openings:
One of our BEST F500 customers has engaged us to help them hire a Regulatory Affairs Specialist to be available to work out of their office in Deerfield, Illinois; details can be found below.
6 months
Please apply or call one of us to learn more
This Contract to hire Position is with one of our Direct Clients. Please submit resumes toRaji – raji.somu (at) divihn (dot) com or call with any questions.
Job Title: Regulatory Affairs Specialist
Job Type: Contract to Hire
Job Location: Deerfield, IL
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.
Responsibilities
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
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 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
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
Interview platform update:
1st round interviews (15 minutes in length, general screening call.
2nd and 3rd round interviews will be Video WebEx at lease 30 minutes in length possibly longer.
Intake Notes:
Minimum of 5 years’ regulatory medical device experience in RA or related healthcare environment (not pharma)
UDI experience
Project management experience
Bachelor’s Degree or country equivalent in related scientific or business systems discipline
Software: Database (nice to have); Microsoft Word, Excel, Outlook, PowerPoint, SharePoint, Access (nice to have) and Project
About us:
DivIHN, the ‘IT Asset Performance Services’ organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Job Requirements:
Regulatory, affairs, data submission requirements, product/facility change management, process support
To Apply: https://www.jobg8.com/Traffic.aspx?Kg361CnmnnqSl5KcAC1KlQt