- Location: Illinois, United States
- Type: Contract
- Job ID: 10404
- Work Setting: On-Site
- Posted: June 17, 2026
- Closing Date: June 7, 2027
- Tax Status: W2
Senior Regulatory Affairs Specialist
12-month Contract
Onsite in Cary, IL
Must be able to work on a W2
Pay Rate: Starting at $60/hr
Requirements
12-month Contract
Onsite in Cary, IL
Must be able to work on a W2
Pay Rate: Starting at $60/hr
Requirements
- Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
- Participate in advocacy activities of a technical, tactical, or strategic nature.
- Evaluate the regulatory environment and provide internal guidance throughout the product lifecycle, including concept, development, manufacturing, and marketing, to ensure product compliance.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
- Identify requirements and potential obstacles for market access distribution, including federal, provincial/territorial, state, reimbursement, and purchasing groups.
- Assist in the development of regulatory strategy and update strategies based on regulatory changes.
- Evaluate proposed products for regulatory classification and jurisdiction.
- Determine local, national, and international requirements and options for regulatory submissions, approval pathways, and compliance activities.
- Provide regulatory information and guidance for product development and planning throughout the product lifecycle to regulatory groups and cross-functional stakeholders.
- Compare regulatory outcomes with initial product concepts and recommend changes or refinements based on regulatory outcomes.
- Negotiate with regulatory authorities throughout the product lifecycle.
- Identify the need for new regulatory procedures and SOPs and participate in their development and implementation.
- Train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
- Assist other departments in the development of SOPs to ensure regulatory compliance.
- Provide regulatory input and technical guidance on global regulatory requirements to product development and sustaining teams.
- Advise stakeholders on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
- Assess the acceptability of quality, preclinical, and clinical documents for submission filing to comply with applicable regulations.
- Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and develop strategies for changes that do not require submissions.
- Provide guidance on preapproval inspections, GCP inspections, and clinical investigator relationships.
- Identify, monitor, and submit applicable reports or notifications to regulatory authorities.
- Provide regulatory information and guidance for proposed product claims and labeling.
- Ensure clinical and nonclinical data, in conjunction with regulatory strategy, align with regulatory requirements and support proposed product claims.
- Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
- Monitor the progress of regulatory authority review processes through appropriate communication channels.
- Communicate and interact with regulatory authorities before and during the development and review of regulatory submissions.
- Collaborate with cross-functional teams during interactions with regulatory authorities, including panel meetings and advisory committees.
- Perform remediation of regulatory documentation in accordance with relevant regulatory requirements for US 510(k).
- Perform remediation of EU MDR Technical Documentation Files in accordance with relevant regulatory requirements for Class IIa medical devices.
- Bachelor’s degree in Engineering, Science, or a related field; or Master’s degree in Regulatory Science.
- Minimum of 6 years of relevant experience.
- Master’s degree or RAC certification preferred.
- Thorough knowledge and understanding of US and international medical device regulations, including direct experience with US 510(k) submissions and EU Class IIa devices.
- Working knowledge of EU MDR Class IIa requirements with expertise in maintaining Technical Documentation Files.
- Experience with regulatory strategy and operations.
- Demonstrated knowledge of regulatory pathways, risk-benefit analysis, submission and registration processes, documentation, compliance, postmarketing surveillance/vigilance, distribution, and obtaining regulatory approvals.
- Strong communication and collaboration skills with internal and external stakeholders.
- Ability to plan, conduct, and supervise assignments under general supervision.
- Ability to proactively review progress, evaluate results, and recommend procedural changes.
- Capable of operating with appreciable latitude for independent action and decision-making.
- Ability to review progress with management and communicate effectively.
- Demonstrated ability to seek out and apply diverse ideas, opinions, and insights.
- Strong interpersonal skills with the ability to work effectively with individuals who think and act differently.
- Receptive to feedback and committed to continuous improvement.
- Ability to evaluate risks, tradeoffs, timing, and available resources to determine the best course of action.
- Ability to navigate organizational dynamics, alliances, and competing priorities.
- Willingness to accept challenging assignments and new opportunities that build capabilities.