Regulatory Affairs Specialist-Medical Devices

iMPact Business Group; Cary (IL); On-site; USD 80,000 - 110,000; Full time

Job summary

iMPact Business Group is seeking a Regulatory Affairs Specialist for a 12-month contract in Cary, Illinois. This role involves developing regulatory strategies and ensuring compliance throughout the product lifecycle in the medical device industry.

The ideal candidate will have a BS in Engineering or Science, with a minimum of 6 years of regulatory experience, particularly with US 510(k) submissions. Excellent communication and analytical skills are essential for success.

Qualifications

• 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.
• Strong understanding of compliance, post-market surveillance, and distribution requirements.

Responsibilities

• Assess regulatory intelligence to develop local and global strategies.
• Assist in developing regulatory strategies based on regulations.
• Evaluate proposed products for regulatory classification.
• Provide regulatory information for product development and planning.
• Prepare and submit electronic and paper regulatory submissions.

Skills

Regulatory pathways

Risk-benefit analysis

Compliance

Post-market surveillance

Education

BS in Engineering, Science, or a related field

MS in Regulatory Science or equivalent preferred

Job description

Our client, a Global Medical Device Manufacture has an immediate opening for a Regulatory Affairs Specialist for a 12 Month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

Position Description

• 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.

What you need

• 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.