23 Results for

Regulatory Manager Jobs in Cincinnati, OH

Jobs

Cincinnati, OH

p>The Global Senior Manager, Regulatory Affairs serves as the senior regulatory leader for Gentherm Medical, responsible for developing and executing regulatory strategies that support global market access, product lifecycle management, and business growth. This role partners closely with executive leadership to assess regulatory risks and opportunities, provides strategic guidance on regulatory matters, and leads interactions with global regulatory authorities.

7 days ago

Cincinnati, OH

$150,000–$205,000 / year

The Director works as part of the Regulatory Affairs team to monitor regulatory activity, coordinate calls and meetings, develop advocacy documents such as comments and letters, help the team prepare for panels and hearings, develop presentations, and provide other assistance as needed.

The Director Regulatory Affairs works to advance the Regulatory Affairs Departments mission of promoting the wireless industrys positions on Federal regulatory policy issues on behalf of and in coordination with CTIAs members.

30+ days ago

Highland Heights, KY

li>Advise Prysmian commercial and procurement teams on contract negotiations as needed, including but not limited to contract language related to regulatory compliance areas of responsibility, and also support generally on commercial contract review as needed. With Diversity, Equity, and Inclusion (DE&I) as part of our Social Ambition 2030 and a strategic pillar of our Company culture, Prysmian is committed to the development of an organization that prioritizes talent, where people feel respected, included, and free to fully express their potential just as they are.

30+ days ago

Cincinnati, OH

Lead regulatory intelligence efforts globally - monitoring emerging regulatory trends (e.g., EU MDR, China NMPA, LATAM registrations) and proactively advising executive leadership on strategic implications. The Director will represent Gentherm Medical with regulatory authorities worldwide and ensure regulatory alignment is embedded into commercialization, portfolio planning, and long-term product lifecycle decisions.

30+ days ago

Mason, OH

MAJOR DUTIES AND RESPONSIBILITIES FDA 510(k) submission o Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality, and regulatory compliance o Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents) o Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format, o Lead submission lifecycle activities, including: o Acceptance Review support (RTA readiness) o Substantive Review coordination o Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications o Updating submission content and modules as required o Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process. This role is a hand-on, execution-focused contractor position responsible for reviewing technical documentation, ensuring regulatory compliance, authoring submission materials, and supporting documentation regulatory strategies across US, EU and global markets.

3 days ago

Cincinnati, OH
p>We are seeking a Regulatory Affairs Principal to play a key role in advancing our pipeline, including the BreathID platform-a unique combination product at the intersection of pharmaceuticals and diagnostics.
The Regulatory Affairs Principal will provide strategic regulatory leadership to support the development, approval, and lifecycle management of pharmaceutical and combination drug-device products.
30+ days ago

New
Mason, OH
p>This role is a hand-on, execution-focused contractor position responsible for reviewing technical documentation, ensuring regulatory compliance, authoring submission materials, and supporting documentation regulatory strategies across US, EU and global markets.
We are seeking an experienced Regulatory Affairs contractor to support the preparation and submission of a US FDA 510k and the development of global regulatory documentation, including EU MDR Class IIa readiness and technical documentation.
4 days ago

Hebron, Kentucky
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The ideal candidate has strong quality systems experience in GMP Quality, OTC drugs, pharmaceuticals, sterile products, medical devices, dietary supplements, cosmetics, personal care, or regulated consumer health products.
ZEISS is looking for a hands-on Quality Manager to help support and scale our growing regulated consumer health portfolio, including OTC sterile eye drops, dietary supplements, cosmetics, and related products.
18 days ago

KY
li>Assures departmental policies, procedures and operations are aligned with (meet or exceed) the regulatory guidelines, rules or laws including those presented by State Board of Pharmacy, Drug Enforcement Agency, Food and Drug Administration, Centers for Medicare and Medicaid Services, The Joint Commission.
Job Summary:
The Manager Pharmacy Technicians is responsible for managing the technician supervisors and overseeing the day to day operations of the department and the pharmacy technician staff ensuring efficient and effective operation of the pharmacy.
30+ days ago

Cincinnati, OH
$95,000–$130,000 / year
Engineering or Technical degree with 8+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience OR Master degree with 5+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience. Interacts with senior management on matters concerning several job areas, departments, and/or customers to accept new concepts, practices and approaches as well as with senior level vendor or customer representatives concerning projects & operational decisions.
30+ days ago

Florence, KY
li>Assures departmental policies, procedures and operations are aligned with (meet or exceed) the regulatory guidelines, rules or laws including those presented by State Board of Pharmacy, Drug Enforcement Agency, Food and Drug Administration, Centers for Medicare and Medicaid Services, The Joint Commission.
Participates in development of processes and procedures to assure appropriate dispensing and distribution of controlled substances through the use of Pyxis C-II Safe, Pyxis Medstation , internal perpetual inventories, Pyxis Anesthesia Stations, Anesthesia boxes, trays or carts and anesthesia waste logs.
13 days ago

Cincinnati, OH
p>As part of working with clients you will help with several aspects of life sciences integrated planning including:
Integrated Planning Strategy: Design and implement IBP/S&OP frameworks tailored to life sciences environments, accounting for regulatory release cycles, CMO/CDMO network complexity, and the distinct planning dynamics of biopharma and med tech product portfolios.
Accenture is a leading solutions and services company that helps the world's leading enterprises reinvent by building their digital core and unleashing the power of AI to create value at speed across the enterprise, bringing together the talent of our approximately 786,000 people, our proprietary assets and platforms, and deep ecosystem relationships.
13 days ago

Mason, OH
$98,448–$168,768 / year
Technical experience required includes the ability to write efficient code to extract, manipulate, and analyze complex datasets using SAS software (Base SAS, Macros, SQL) to generate reports, tables, and listings as well as advanced MS Excel skills (VLOOKUP, pivot tables, Power Query, macros, nested if functions), intermediate MS Access skills (SQL, select/append/make table queries), and experience extracting data from a data warehouse using Snowflake or Python or similar software. For URAC accredited areas, the following professional competencies apply: Associates in this role are expected to have strong oral, written and interpersonal communication skills, problem-solving skills, facilitation skills, and analytical skills.
24 days ago

Cincinnati, OH
$144,200–$265,600 / year
The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.
30+ days ago

Edgewood, Kentucky
li>Assures departmental policies, procedures and operations are aligned with (meet or exceed) the regulatory guidelines, rules or laws including those presented by State Board of Pharmacy, Drug Enforcement Agency, Food and Drug Administration, Centers for Medicare and Medicaid Services, The Joint Commission. The Manager Pharmacy Technicians is responsible for managing the technician supervisors and overseeing the day to day operations of the department and the pharmacy technician staff ensuring efficient and effective operation of the pharmacy.
30+ days ago

Cincinnati, OH
$189,200–$372,900 / year
p>The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.
11 days ago

Florence, Kentucky
li>Assures departmental policies, procedures and operations are aligned with (meet or exceed) the regulatory guidelines, rules or laws including those presented by State Board of Pharmacy, Drug Enforcement Agency, Food and Drug Administration, Centers for Medicare and Medicaid Services, The Joint Commission.
Participates in development of processes and procedures to assure appropriate dispensing and distribution of controlled substances through the use of Pyxis C-II Safe, Pyxis Medstation , internal perpetual inventories, Pyxis Anesthesia Stations, Anesthesia boxes, trays or carts and anesthesia waste logs.
14 days ago

OH
$120,200–$140,000 / year
Lead and contribute to end-to-end delivery for Generis CARA and associated regulatory technology platforms - including requirements gathering, solution design, system configuration, content template development, and user acceptance testing. Our purpose comes through in our work with clients that enables impact and value in their organizations, as well as through our own investments, commitments, and actions across areas that help drive positive outcomes for our communities.
14 days ago

Cincinnati, OH
This role will entail direct involvement with research participants (children, adolescents, and caregivers), oversight of regulatory compliance, data management support, and leadership within a team of other research coordinators and trainees (e.g., summer and doctoral students, residents, postdoctoral fellows). This position will also include providing strategic support across the Division to promote best practices in research operations, advancing REDCap capabilities, and supporting the successful launch and management of newly funded studies.
27 days ago

Cincinnati, OH
$61,401.60–$78,291.20 / year
Create case report forms (CRFs) in consultation with other team members, as needed, using existing study data information to promote efficient data collection and data entry.
Study Conduct/ Clinical Research Practice - Serve as a resource for others for all aspects of conducting a clinical trial for complex and multi-center trials.
11 days ago

Hebron, KY
Full time
Leads the development and implementation of regional quality policies, procedures, systems and initiatives that continuously improve systems and product quality levels, responsible for the quality related KPI's based on global Zeiss directives. This position is responsible for leading both the strategic and operational aspects of Regulatory Affairs objectives for assigned products, life cycle management initiatives and acquisitions including NALA regulatory strategy, regulatory submissions, and interaction with regulatory authorities.
30+ days ago

Hebron, Kentucky
The role serves as the principal quality and compliance gatekeeper, with independent decision-making authority over supplier qualification, audits, regulatory readiness, storage/distribution, and recall management.
The Senior Supplier Quality Expert ensures the quality, compliance, and regulatory adherence of EyeCare products and nutritional supplements distributed and wholesaled by Zeiss Vision Care.
30+ days ago

OH
$50,000–$72,500 / year
p>The Supply Chain Analyst I supports supply chain master data activities and system-driven processes that enable new product introductions, ongoing manufacturing operations, and regulatory compliance. This role assists in maintaining accurate data within enterprise systems such as SAP and supports documentation and process activities, bill of materials (BOM), and operational changes.
30+ days ago

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Regulatory Manager Jobs in Cincinnati, OH

Senior Manager, Regulatory Affairs Gentherm Inc

Director, Regulatory Affairs CTIA

North America Corporate Counsel - Regulatory Affairs Prysmian SpA

Global Director of Regulatory Affairs Gentherm Inc

Regulatory Affairs Contractor The Kemtah Group, Inc.

Regulatory Affairs Principal, Pharmaceutical and Combination Products Meridian Bioscience Inc

Regulatory Affairs Contractor Belcan LLC

Quality Manager, Consumer Health Products ZEISS

Manager Pharmacy Technicians St. Elizabeth Healthcare

Value Stream Manager Integra LifeSciences

Pharmacy Manager St. Elizabeth Healthcare

Life Sciences Supply Chain and Operations - Supply Chain Planning Manager Accenture Plc

Business Change Manager Sr Elevance Health Inc

Manager, Industry Solutions, Veeva Life Science Deloitte Touche Tohmatsu Ltd

Manager Pharmacy Technicians SEH Saint Elizabeth Medical Center

Life Science Veeva Senior Manager Deloitte Touche Tohmatsu Ltd

Pharmacy Manager SEH Saint Elizabeth Medical Center

Managed Services Sr. Consultant Deloitte Touche Tohmatsu Ltd

Clinical Research Coordinator IV or Senior - Behavioral Medicine & Clinical Psychology Cincinnati Children's Hospital Medical Center

Clinical Research Coordinator IV - Bone Marrow Transplantation Cincinnati Children's Hospital Medical Center

Head of Quality & EHS (Director) Zeiss Group

Senior Supplier Quality Expert ZEISS

Supply Chain Analyst I Resilience Biotechnologies Inc

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