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Regulatory & Filings Analyst II

AmTrust Financial Services, Inc.
Cleveland, OH
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Supports Legal/Regulatory Department across several AmTrust U.S. offices. ...
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Summary
About the job:
Has shared responsibility for assisting or leading a variety of regulatory & compliance, product development and implementation matters. Maintains a solid understanding of AmTrust’s mission, vision, and values. Upholds the standards of the AmTrust organization. Prepares insurance product filings (with minimal supervision) for commercial package coverages, such as commercial auto, general liability, property and commercial umbrella and niche products (e.g., contractors, excess, and professional liability) from...
Location:
Cleveland, OH
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Specialists
Career Level / Education:
Bachelor's degree
Salary:
High Income Jobs ($80K-$99K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
3
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

Labeling Specialist - Columbus, OH

Abbott Laboratories
Columbus, OH
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Abbott is a global healthcare leader that helps people live more fully at ...
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Summary
About the job:
all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading...
Location:
Columbus, OH
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Specialists
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
3
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

Sr. Regulatory Affairs Specialist-CT/AMI

BioTelemetry
Orange, OH
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Job Title Sr. Regulatory Affairs Specialist-CT/AMI Job Description The ...
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Summary
About the job:
Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim landscape, legislative initiatives, and marketing strategy. Your role: - The Senior RA Specialist provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance...
Location:
Orange, OH
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Specialists
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
Regulatory Affairs Certification
Medical Device Directive Certification
Workkeys
Applied Math
3
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

Senior Regulatory Affairs Specialist

BioTelemetry
Orange, OH
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Job Title Senior Regulatory Affairs Specialist Job Description Senior ...
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Summary
About the job:
Regulatory Affairs Specialist (U.S. Hub based location) The Senior Regulatory Affairs Specialist is responsible for regulatory compliance, strategy and submissions related to accessory devices/products (mixture of class 1 and class 2). The Senior Regulatory Affairs Specialist will leverage their industry knowledge to guide regulatory strategies efficiently. Your role: - Develop global regulatory strategies to meet business objectives and collaborate across a matrixed organization to ensure global success of products....
Location:
Orange, OH
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Specialists
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
Regulatory Affairs Certification
Medical Device Directive Certification
Workkeys
Applied Math
3
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

Regulatory affairs counsel

Crosscountry Mortgage, LLC.
Cleveland, OH
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Description CrossCountry Mortgage (CCM) is one of the nation’s top 3 retail ...
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Summary
About the job:
mortgage lenders with more than 7,000 employees operating nearly 600 branches across all 50 states. We have been recognized nine times on the Inc. 5000 list of America’s fastest-growing private businesses and have received countless awards for our standout culture. Through our dedication to getting it done, we make every mortgage feel like a win. A culture where you can grow! CCM has created an exceptional culture driving employee engagement, exceeding employee expectations, and directly impacting company success. At...
Location:
Cleveland, OH
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Specialists
Career Level / Education:
Doctoral or professional degree
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
American Bar Association
Workkeys
Applied Math
5
Graphic Literacy
5
Workplace Documents
7
apply
Detailed Job Information

Specialist-Regulatory Affairs

Children'S Hospital Medical Center
Cincinnati, OH
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Specialist-Regulatory Affairs - 150760 Description SUBFUNCTION DEFINITION: ...
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About the job:
Ensure CCHMC is meeting all regulatory requirements, policies and procedures. Identifies and mitigates risks. REPRESENTATIVE RESPONSIBILITIES ·Protocol - Apply a comprehensive understanding of research regulations, ethics and guidelines, analyze research protocols submissions (new protocols, continuing review, changes to protocols, one-time use request and adverse events) to determine compliance with regulations. - Oversee the review and correspondence of research protocols. - Use independent judgment to interpret,...
Location:
Cincinnati, OH
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Specialists
Career Level / Education:
Bachelor's degree
Salary:
Upper Middle Income Jobs ($50K-$79K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
3
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

Principal Regulatory Affairs Specialist

BioTelemetry
Orange, OH
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Job Title Principal Regulatory Affairs Specialist Job Description This ...
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Summary
About the job:
requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
Location:
Orange, OH
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Specialists
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
3
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

Remote - Sr. Regulatory Affairs Associate - Pharmaceuticals

Fresenius Medical Care
Delaware, OH
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This position can be fully remote PURPOSE AND SCOPE: Ensures company ...
Details
Summary
About the job:
products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for assigned projects. Prepares for agency interactions by writing and organizing associated documentation, including letters and briefing packages. Reviews and advises on manufacturing and control changes for marketed products, labels and...
Location:
Delaware, OH
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Specialists
Career Level / Education:
Bachelor's degree
Salary:
High Income Jobs ($80K-$99K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
3
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

Principal Regulatory Affairs Specialists

Hikma Pharmacueticals USA, Inc.
Columbus, OH
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271315424 Job Duties : Serve as a Principal Regulatory Affairs Specialist ...
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Summary
About the job:
for regulatory activities of R&D and/or lifecycle submissions to the U.S. FDA, including, but not limited to the compilation, review, and submission of pre-approval (R&D) and/or post-approval (lifecycle) submissions, such as original applications, amendments & deficiency responses, annual reports, supplements, supplement deficiency responses, and general correspondence for all regulatory submissions with a focus on Chemistry, Manufacturing, and Controls (“CMC”) and Labeling. Provide support in applicable team meetings,...
Location:
Job Type:
Occupation:
Career Level / Education:
Salary:
Certifications / Licenses:
Workkeys
Applied Math
3
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

Remote - Regulatory Affairs Associate II Pharma

Fresenius Medical Care
Delaware, OH
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This position can be fully remote PURPOSE AND SCOPE: Ensures company ...
Details
Summary
About the job:
products meet regulatory requirements by supporting all assigned regulatory aspects of product approval and post-marketing compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for assigned projects. Prepares for agency interactions by writing and organizing associated documentation, including letters and briefing packages. Reviews and advises on manufacturing and control changes for marketed products, labels and...
Location:
Delaware, OH
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Specialists
Career Level / Education:
Bachelor's degree
Salary:
High Income Jobs ($80K-$99K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
3
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information
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