Job Description
Job Title:
Senior Regulatory Affairs Specialist Location: Cary, Illinois Type: Contract Compensation: $58- $64/hr Work Model: Onsite
Overview:
Join a leading medical device organization as a Regulatory Affairs professional supporting global regulatory strategy, compliance, and market access initiatives. This contract role is ideal for someone with strong U.S. 510(k) and EU MDR Class IIa experience who thrives in a collaborative, fast-paced environment and enjoys influencing products throughout their lifecycle.
Responsibilities:- Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
- Participate in advocacy activities of a more advanced technical and/or tactical or strategic nature
- Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, 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 (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)Assist in the development of regulatory strategy and update strategy based upon regulatory changes
- Evaluate proposed products for regulatory classification and jurisdiction
- Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
- Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
- Compare regulatory outcomes with initial product concepts and recommend changes or refinements based on initial regulatory outcomes
- Negotiate with regulatory authorities throughout the product lifecycle
- Identify the need for new regulatory procedures, SOPs, and participate in development and implementation
- Help 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 of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
- Assess the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
- Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategize (if appropriate) for changes that do not require submissions
- Provide knowledge and 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/labeling
- Ensure that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
- Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
- Monitor the progress of the regulatory authority review process through appropriate communications with the agency
- Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
- Work with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
- Remediation of regulatory documentation in accordance with relevant regulatory requirements for US 510(k)
- Remediation of EU MDR Technical Documentation File in accordance with relevant regulatory requirements for Class IIa medical device
Requirements:- BS in Engineering, Science, or related degree; or MS in Regulatory Science 6+ years of experienceMS or RAC(s) preferred
- Thorough knowledge and understanding of US and International Medical Device Regulations with direct experience in US 510(k) and EU Class IIa devices
- Working knowledge of EU MDR Class IIa devices with expertise in maintaining a Technical Documentation File
- Technical and management skills and engaged in regulatory strategy and operations
- Demonstrate knowledge and skills in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation, compliance, post marketing surveillance/vigilance; and distribution
System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. Ref: #558-Scientific
