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Regulatory Affairs Specialist

JBL Resources

Cary, IL

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JOB DETAILS
SALARY
$64.25
SKILLS
Analysis Skills, Clinical Data, Clinical Study Publications, Communication Skills, Cross-Functional, Documentation, Drug Development, GCP (Good Clinical Practices), Human Resources, Intelligence Analysis, Logistics, Maintain Compliance, Manufacturing, Manufacturing Requirements, Marketing, Medical Equipment, Negotiation Skills, Pre-Clinical Trials, Product Development, Product Lifecycle, Product Lifecycle Management, Product Planning, Product Support, Product Testing, Purchasing/Procurement, Regulations, Regulatory Requirements, Regulatory Submissions, Reimbursement, Requirements Management, Risk Analysis, Standard Operating Procedures (SOP), Strategic Planning, Supply Chain Management, Supply Chain Operations, Surveillance, Technical Leadership, Technical Writing
LOCATION
Cary, IL
POSTED
10 days ago
Regulatory Affairs Specialist
Location: Cary, Illinois
About Our Client:
Our client has built a high-trust, people-first culture driven by real employee feedback and a commitment to innovation, collaboration, and performance. Known for fostering an environment where employees feel valued, supported, and empowered to grow, the organization continues to set itself apart as an employer of choice. Working here means joining a team of top technical professionals bringing cutting-edge products to the forefront—offering driven individuals the opportunity to make a meaningful impact every day.
Key Responsibilities:
  • Assessing regulatory intelligence to assist in developing local, regional, and global regulatory strategies.
  • Participating in advocacy activities of a more advanced technical, tactical, or strategic nature.
  • Evaluating the regulatory environment and contributing to internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
  • Anticipating regulatory obstacles and emerging issues throughout the product lifecycle and developing solutions.
  • Identifying requirements and potential obstacles for market access and distribution (federal, provincial/territorial, reimbursement, purchasing groups, etc.).
  • Assisting in developing regulatory strategies and updating them based on regulatory changes.
  • Evaluating proposed products for regulatory classification and jurisdiction.
  • Determining requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
  • Providing regulatory information and guidance for product development and planning throughout the product lifecycle to regulatory teams and other stakeholders.
  • Comparing regulatory outcomes with initial product concepts and recommending changes or refinements based on regulatory findings.
  • Negotiating with regulatory authorities throughout the product lifecycle.
  • Identifying the need for new regulatory procedures and SOPs, and participating in their development and implementation.
  • Helping train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
  • Assisting other departments in developing SOPs to maintain regulatory compliance.
  • Providing regulatory input and technical guidance on global regulatory requirements to product development and sustaining teams.
  • Advising stakeholders on regulatory requirements for quality, preclinical, and clinical data to meet applicable standards.
  • Assessing the acceptability of quality, preclinical, and clinical documents for submission filing to ensure regulatory compliance.
  • Evaluating proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposing plans or strategies for changes that do not require submissions.
  • Providing knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships.
  • Identifying, monitoring, and submitting applicable reports or notifications to regulatory authorities.
  • Providing regulatory information and guidance for proposed product claims and labeling.
  • Ensuring clinical and nonclinical data, aligned with regulatory strategy, are consistent with requirements and support product claims.
  • Preparing and submitting electronic and paper regulatory submissions according to relevant regulations and guidelines.
  • Monitoring the progress of regulatory reviews through appropriate communications with agencies.
  • Communicating and interacting with regulatory authorities before and during submission review processes using suitable communication tools.
  • Working with cross-functional teams for interactions with regulatory authorities, including panel meetings and advisory committees.
  • Remediating regulatory documentation to comply with US 510(k) requirements.
  • Remediating EU MDR Technical Documentation Files for Class IIa medical devices in accordance with relevant standards.
Qualifications:
  • BS in Engineering, Science, or a related field; MS in Regulatory Science or equivalent preferred.
  • Minimum 6 years of experience in regulatory affairs within the medical device industry.
  • Extensive knowledge of US and international regulations, especially US 510(k) submissions and EU MDR Class IIa device requirements.
  • Proven expertise in regulatory pathways, risk-benefit analysis, and regulatory documentation.
  • Strong understanding of compliance, post-market surveillance, and distribution requirements.
  • Excellent analytical, evaluative, and decision-making skills in complex situations.
  • Effective communicator capable of negotiating with regulatory bodies and collaborating internally.
  • Experience with regulatory strategies for new product development and lifecycle management.
  • Knowledge of global markets beyond US and EU.
  • NO C2C CANDIDATES

Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company
 

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