Regulatory Affairs Associate

Automated Systems, Inc.

Job Description

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.

  • Open to REMOTE candidates, Hybrid model would be preferred with onsite office location in Deerfield, IL.


Requirements

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 in related scientific, IT, or business systems discipline, required
• Minimum of 1-year regulatory experience in RA (medical device) 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)

Job Requirements

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 in related scientific, IT, or business systems discipline, required • Minimum of 1-year regulatory experience in RA (medical device) 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)

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