Regulatory Affairs Specialist
4 weeks ago
Job Summary
The Regulatory Affairs Specialist will be responsible for planning and executing state and federal regulatory activities necessary for Chemical Compliance of our products. This includes preparing comprehensive Chemical Compliance regulatory strategies for new products markets, and post-market product changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements.
Key Responsibilities
- Review complex regulatory issues with RA management and other team members by applying their specialized experience to solve issues and complete short-term department goals
- Determine the requirements for completing and maintaining product chemical requirements
- Recommend regulatory pathways and strategies
- Review and provide feedback on documentation and supporting evidence to ensure applicable regulatory requirements are met
- Complete and maintain regulatory filings by collaborating with internal and external groups, evaluating supporting technical information, writing appropriate summary documentation, and supporting the response to non-conformances and questions from regulators
- Participate in the development, review, and substantiation of product labeling and claims for products that include requirements from EPA CAA, CPSC, Right to Know Laws, etc.
Requirements
- S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related
- 2 years of experience in medical device regulatory affairs or quality assurance
- Understanding of the current Regulatory environment and demonstrating the ability to perform within
- Ability to evaluate information to determine compliance with standards, laws, and regulations
Benefits
For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more.
Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps.
Every day, we're focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace.
-
Quality and Regulatory Compliance Expert
4 weeks ago
Northbrook, Illinois, United States Crate and Barrel Full timeWe're seeking a highly skilled Quality and Regulatory Compliance Specialist to join our team at Crate and Barrel. This role is responsible for managing product quality testing programs with internal and external partners to ensure that products meet quality, safety, and regulatory requirements in the US, Canada, and select international markets.This is a...
-
Northbrook, Illinois, United States Astellas Pharma Inc. Full timeJob SummaryWe are seeking a highly skilled Medical Lead to join our team at Astellas Pharma Inc. in the US. The successful candidate will be responsible for leading the development and execution of strategic medical plans for assigned products within the Therapeutic Area (TA) that are aligned with the global Core Medical Plan (CMP).Key...
-
Field Engineering Project Specialist
4 weeks ago
Northbrook, Illinois, United States UL Full timeJob Summary:UL is seeking a highly skilled Field Engineering Project Specialist to join our Product Safety Field Evaluation Team. As a Field Engineering Project Specialist, you will be responsible for independently managing execution and timely completion of Field Evaluation projects with minimum supervision.Key Responsibilities:Develop UL requirements, test...
-
Credentialing and Billing Specialist
4 weeks ago
Northbrook, Illinois, United States Josselyn Full timeJob SummaryThe Credentialing and Billing Specialist at Josselyn is responsible for maintaining active status for all clinicians and physicians by successfully completing the initial and subsequent credential packages as required by regulatory agencies, commercial payors, and Medicaid and Medicare. This includes ensuring that all clinical staff have the...
-
Credentialing and Billing Specialist
4 weeks ago
Northbrook, Illinois, United States Josselyn Full timeCredentialing and Billing Specialist Job SummaryThe Credentialing and Billing Specialist at Josselyn plays a vital role in maintaining active status for all clinicians and physicians by successfully completing the initial and subsequent credential packages as required by regulatory agencies, commercial payors, and Medicaid and Medicare. This includes...
-
Healthcare Provider Credentialing Specialist
2 days ago
Northbrook, Illinois, United States USA Clinics Group Full timeWe are seeking a dedicated Credentialing Specialist to support the growth of our USA Clinics Group. The ideal candidate will possess excellent organizational skills, attention to detail, and effective communication abilities.About the RoleThis position is responsible for maintaining active provider status by completing initial and subsequent credentialing...
-
Credentialing and Billing Specialist
4 weeks ago
Northbrook, Illinois, United States Josselyn Full timeJob SummaryJosselyn is seeking a skilled Credentialing and Billing Specialist to join our team. The successful candidate will be responsible for maintaining active status for all clinicians and physicians by successfully completing the initial and subsequent credential packages as required by regulatory agencies, commercial payors, and Medicaid and...
-
Certification Engineer
4 weeks ago
Northbrook, Illinois, United States Leviton Full timeAbout the RoleLeviton is seeking a highly skilled Certification Engineer to join our team. As a key member of our engineering department, you will be responsible for ensuring our products meet the highest standards of safety and quality.Key Responsibilities:Develop and maintain project plans for certification projects, including timelines and...
-
Staff Pharmacist
4 weeks ago
Northbrook, Illinois, United States CVS Health Full timeTransforming Healthcare with Compassion and ExpertiseAt CVS Health, we're committed to delivering exceptional patient care and advancing the field of pharmacy. As a Staff Pharmacist, you'll play a critical role in leading our team of healthcare professionals and driving innovative solutions to improve patient outcomes.Key Responsibilities:Patient Safety:...
-
Tax Manager, State Compliance Specialist
1 month ago
Northbrook, Illinois, United States CF Industries Employee Services LLC Full timeJob Summary:The State Tax Return Filing and Audit Lead will be responsible for managing all aspects of CF Industries' state tax return filings and state and local audits. This role will also assist with the company's state income tax provision and provide tax law analysis and planning.Key Responsibilities:Manage and supervise all aspects of state tax...
-
Product Regulatory Compliance Specialist
4 weeks ago
Northbrook, Ohio, United States CF Industries Employee Services LLC Full timeJob DescriptionAt CF Industries, our mission is to provide clean energy to feed and fuel the world sustainably. Our employees are focused on safe and reliable operations, environmental stewardship, and disciplined capital and corporate management.We are seeking a Product Regulatory Compliance Specialist to support our EHSQ Mission by coordinating corporate...
-
Medical Director, Ophthalmology, ACP
2 weeks ago
Northbrook, Ohio, United States Astellas Pharma Inc. Full timeAbout the RoleWe are seeking a highly skilled Medical Director to lead our Ophthalmology team in the ACP department. As a key member of our Medical Affairs team, you will be responsible for developing and executing strategic medical plans that align with our global Core Medical Plan (CMP).Key ResponsibilitiesLead the development and execution of strategic...
-
Credentialing Specialist
4 weeks ago
Northbrook, United States USA Clinics Group Full timeUSA Clinics Group is growing and seeking a motivated Credentialing Specialist to join our team! The Credentialing Specialist is responsible for maintaining active status for all providers by successfully completing initial and subsequent credentialing packages as required by Medicare and Medicaid, commercial payers, hospitals, and regulatory agencies....
-
Northbrook, United States Astellas Pharma Inc. Full timeResponsibilities :Support the Senior Director, HEOR in developing and implementing MA-US TA research strategyAssist HEOR Senior Director mentor and develop a high performing team through development of in-house talentProvide oversight of HEOR expertise and input for projects/initiatives, protocol development, regulatory documents, scientific publications,...
-
Credentialing Specialist
1 month ago
Northbrook, United States Josselyn Full timeJob Summary The Credentialing and Billing Specialist is responsible for maintaining active status for all clinicians and physicians by successfully completing the initial and subsequent credential packages as required by regulatory agencies, commercial payors, and Medicaid and Medicare. This includes ensuring that all clinical staff have the necessary...
-
Credentialing Specialist
3 weeks ago
Northbrook, United States Josselyn Full timeLocation: Northbrook, IL (100% onsite - no remote option)Hours: Monday - Friday, 8:30 AM - 4:30 PMJob SummaryThe Credentialing and Billing Specialist is responsible for maintaining active status for all clinicians and physicians by successfully completing the initial and subsequent credential packages as required by regulatory agencies, commercial payors,...
-
Credentialing Specialist
1 week ago
Northbrook, United States Josselyn Full timeLocation: Northbrook, IL (Onsite - no remote option)Hours: Monday - Friday, 8:30 AM - 4:30 PMJob Summary The Credentialing and Billing Specialist is responsible for maintaining active status for all clinicians and physicians by successfully completing the initial and subsequent credential packages as required by regulatory agencies, commercial payors, and...
-
Credentialing Specialist
2 weeks ago
Northbrook, United States Josselyn Full timeLocation: Northbrook, IL (100% onsite - no remote option)Hours: Monday - Friday, 8:30 AM - 4:30 PMJob Summary The Credentialing and Billing Specialist is responsible for maintaining active status for all clinicians and physicians by successfully completing the initial and subsequent credential packages as required by regulatory agencies, commercial payors,...
-
Certification Engineer
4 weeks ago
Northbrook, Ohio, United States Leviton Full timeAbout Leviton At Leviton, we develop innovative solutions that enhance the functionality and efficiency of everyday spaces. Our team is dedicated to creating products that make a lasting impact.With a rich history of over 115 years, Leviton has established itself as a leader in the electrical industry. We are committed to pushing the boundaries of what is...
-
Payroll and Compliance Specialist
1 week ago
Northbrook, United States Josselyn Full time $55,000 - $65,000Job SummaryTo be considered for an interview, please make sure your application is full in line with the job specs as found below.The Payroll and Compliance Specialist is the expert on payroll operations, employment and payroll-related HR compliance, and payroll systems. Key responsibilities include processing biweekly payroll, conducting regular...
-
Payroll and Compliance Specialist
1 week ago
Northbrook, United States Josselyn Full timeJob SummaryThe Payroll and Compliance Specialist is the expert on payroll operations, employment and payroll-related HR compliance, and payroll systems. Key responsibilities include processing biweekly payroll, conducting regular reconciliations and audits, ensuring compliance with payroll and HR regulations, and developing training programs for staff on...
-
Product Steward
2 weeks ago
Northbrook, United States CF Industries Full timeAt CF Industries, our mission is to provide clean energy to feed and fuel the world sustainably. Our employees are focused on safe and reliable operations, environmental stewardship, and disciplined capital and corporate management. By joining CF, you will be part of a team that brings their varied experiences, wide-ranging knowledge and diverse talents...
-
Credentialing Specialist
22 hours ago
Northbrook, IL, United States Josselyn Full timeLocation: Northbrook, IL (Onsite - no remote option) Hours: Monday - Friday, 8:30 AM - 4:30 PM Job Summary The Credentialing and Billing Specialist is responsible for maintaining active status for all clinicians and physicians by successfully completing the initial and subsequent credential packages as required by regulatory agencies, commercial payors,...