Top 107 Senior chemical process Jobs in Cleveland, Oh

Senior Director of Regulatory Affairs
Cleveland Diagnostics Inc. —Cleveland, OH
- $125,000 - $225,000 a year
- Full-time
- Hybrid work
- Microsoft Word
- Microsoft Excel
- Office
- Disability insurance
- Health insurance
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20h
Process Excellence Consultant / Manager / Senior Manager
Accenture —Cleveland, OH
- $59,100 - $196,000 a year
- Full-time
- Analysis skills
- US work authorization
- Military encouraged
- Paid holidays
- Disability insurance
6d
Senior Product Development Chemist
Arclin USA —Cleveland, OH
- Urgently hiring
- Bachelor's degree
- Senior level
- Communication skills
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8d
Senior Process Innovation Chemist
Lubrizol —Wickliffe, OH
- Full-time
- Analysis skills
- Continuous improvement
- Doctor of Philosophy
- Health savings account
- Paid holidays
EHS Senior Specialist
Avantor —Solon, OH
- Full-time
- Engineering
- Public speaking
- Mid-level
Sr. Nondestructive Test Technician
Curtiss-Wright —Middleburg Heights, OH
- $29 - $32 an hour
- Full-time
- ERP systems
- Mid-level
- Trade school
- Health insurance
- Dental insurance
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6d
Senior Analyst, Mergers & Acquisitions
Lubrizol —Wickliffe, OH
- Mid-level
- 3 years
- Finance
- Health savings account
- Paid holidays
Global Change Management Leader, Customer Experience CoE
Lubrizol —Wickliffe, OH
- Hybrid work
- Office
- Bachelor's degree
- Continuous improvement
Crisis Response Specialist
The Centers —Cleveland, OH
- $28.84 - $32.21 an hour
- Full-time
- Mid-level
- Residential
- Bachelor's degree
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6d
Senior Process Engineer
Middough Inc. —Cleveland, OH
- $85,000 - $140,000 a year
- Full-time
- Bachelor of Science
- Engineering
- 11+ years
- AD&D insurance
- Paid holidays
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City of Shaker Heights – Senior Housing Inspector
BOCONEO —Shaker Heights, OH
- Data analysis skills
- Research
- Office
Director, Remote Operations Control Center
Airgas —Independence, OH
- $160,000 - $190,000 a year
- Full-time
- Hybrid work
- Bachelor of Science
- Engineering
- Office
- Paid jury duty
- Commuter assistance
Senior Director, Global Gas Technology
Steris —Mentor, OH
- $167,450 - $216,700 a year
- Full-time
- Remote
- Bachelor's degree
- Travel
- Senior level
- Paid holidays
- Disability insurance
Sr. Scientist I - Beachwood, OH
Master Builders Solutions Admixtures US, LLC —Beachwood, OH
- $115,000 - $135,000 a year
- Full-time
- Ability to climb stairs
- Master's degree
- Analysis skills
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Senior Housing Inspector
City of Shaker Heights —Cleveland, OH
- Up to $75,000 a year
- Full-time
- Background check
- Data analysis skills
- Research
- Health insurance
- Dental insurance
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14d
Senior Research Assistant 1
Case Western Reserve University —Cleveland, OH
- Full-time
- Bachelor of Science
- Writing skills
- Mid-level
Senior Health, Safety & Environmental Specialist
Steris —Mentor, OH
- $79,687.50 - $103,125.00 a year
- Full-time
- 5 years
- High school diploma or GED
- Analysis skills
- Paid holidays
- Disability insurance
Senior Production Manager
H.B. Fuller —Chagrin Falls, OH
- $130,000 - $150,000 a year
- Bachelor of Science
- English
- Conflict management
- Paid holidays
- Health insurance
Senior Sourcing Specialist - ESG
Shurtape Technologies —Avon, OH
- Full-time
- Office
- 3 years
- Analysis skills
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Powder Coatings Chemist
Royal Powder —Cleveland, OH
- $95,000 - $110,000 a year
- Full-time
- Mid-level
- Analysis skills
- Bachelor's degree
- Relocation assistance
- Health insurance
Quick Apply

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senior chemical process jobs near cleveland, oh

Senior Director of Regulatory Affairs

Cleveland Diagnostics Inc.
Cleveland, OH

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Job Details

Full-time
$125,000 - $225,000 a year
20 hours ago

Benefits

Stock options
Disability insurance
Health insurance
Dental insurance
Paid time off
Snacks provided
Dependent health insurance coverage
Vision insurance
Flexible schedule
Referral program
Retirement plan

Qualifications

FDA submissions
Regulatory/legal compliance standards in production
Design controls
Biomedical regulatory compliance

Full Job Description

Senior Director of Regulatory Affairs

Job Title: Senior Director of Regulatory Affairs

Reports to: Chief Medical Officer

Job Overview

The Senior Director of Regulatory Affairs will provide strategic and operational leadership for regulatory affairs activities supporting Cleveland Diagnostics' in vitro diagnostic (IVD) and laboratory developed test (LDT) product portfolio, including tests/assays intended for early cancer detection and other clinical indications. This role will lead the development, execution, and maintenance of global regulatory strategies across the full product lifecycle, including pre-market submissions, post-market obligations, regulatory agency interactions, and ongoing compliance with applicable U.S. and international regulatory requirements.

The Senior Director will serve as a regulatory leader for FDA-regulated IVD products, including PMA, PMA supplement, 510(k), amendment, annual report, and post-approval submission activities, as well as international regulatory documentation, including IVDR Technical Documentation and other jurisdictional requirements where applicable. This position requires strong strategic judgment, integrity, deep knowledge of IVD and other regulatory pathways, excellent technical writing and review capabilities, and the ability to lead cross-functional teams through complex regulatory programs.

The role is expected to operate at both a strategic and hands-on level, providing executive-level regulatory guidance while ensuring high-quality execution of submissions, regulatory documentation, and compliance activities.

Essential Duties & Responsibilities

Regulatory Strategy and Leadership

Lead the development and execution of regulatory strategies for new and existing IVD and LDT products throughout the product lifecycle.
Serve as the company's senior regulatory subject matter expert for U.S. FDA and applicable international regulatory requirements related to IVD and LDT products.
Provide strategic regulatory guidance to executive leadership, product development teams, clinical operations, medical affairs, quality assurance, manufacturing, legal/compliance, and commercial stakeholders.
Assess regulatory pathways, submission requirements, approval risks, and post-market obligations for new products, expanded indications, product modifications, and lifecycle management activities.
Translate regulatory requirements into actionable development, clinical, medical affairs, quality, manufacturing, and submission plans.
Anticipate regulatory risks and develop mitigation strategies to support timely product development, approval, launch, and post-market maintenance.
Lead interactions when appropriate with outside legal, regulatory, and statistical consultants.

Regulatory Submissions and Agency Interactions

Lead the planning, preparation, review, submission, and maintenance of regulatory submissions and related documentation, including PMAs, PMA supplements, amendments, annual reports, 510(k)s, FDA correspondence, and international regulatory dossiers.
Oversee preparation and maintenance of IVDR Technical Documentation and other international regulatory documentation, as applicable.
Lead or support interactions with FDA, Notified Bodies, and other regulatory authorities, including meeting requests, pre-submission activities, responses to questions, deficiency responses, and post-approval communications.
Ensure regulatory submissions are accurate, complete, scientifically sound, strategically positioned, and submitted in accordance with applicable timelines and requirements.
Provide senior-level review of technical, clinical, analytical, manufacturing, labeling, and quality documentation for regulatory consistency and compliance.

Product Lifecycle and Change Management

Lead regulatory assessment of product development activities, design changes, manufacturing changes, process changes, labeling changes, and clinical or analytical updates.
Determine appropriate regulatory reporting or submission requirements for product and process changes.
Partner with Quality Assurance, Manufacturing, IVD Test Development, Clinical Operations, and other functions to ensure changes are properly assessed, documented, and implemented in compliance with regulatory requirements.
Oversee maintenance of product approvals, listings, registrations, supplements, amendments, post-approval reports, and related regulatory records on a domestic and international basis.

Post-Market Regulatory Compliance

Provide leadership for post-market regulatory activities, including post-market surveillance, vigilance reporting, adverse event assessment, field action support, annual reporting, and regulatory record maintenance.
Ensure post-market regulatory obligations are identified, tracked, and fulfilled in accordance with FDA, IVDR, and other applicable requirements.
Support quality system activities related to complaints, CAPAs, nonconformances, audits, inspections, and regulatory reporting decisions.
Monitor evolving regulatory requirements, guidance documents, standards, and enforcement trends and communicate relevant implications to internal stakeholders.

Cross-Functional Collaboration and Organizational Leadership

Lead cross-functional regulatory planning and execution with Clinical Operations, Legal and Compliance, IVD Test Development, Quality, Manufacturing, Commercial, Medical Affairs, and external consultants.
Provide regulatory leadership for product development teams, clinical study teams, design control activities, and launch readiness planning.
Build, manage, and mentor regulatory affairs personnel, consultants, and vendors as needed.
Establish clear regulatory roles, timelines, deliverables, and accountability across internal and external teams.
Promote a culture of regulatory excellence, scientific rigor, documentation discipline, and compliance.

Regulatory Systems, Policies, and Documentation

Lead the development, implementation, and maintenance of regulatory policies, procedures, templates, regulatory intelligence processes, and submission standards.
Ensure regulatory documentation systems support accuracy, traceability, version control, and inspection readiness.
Oversee regulatory document management practices for large, complex technical files and submission packages.
Support continuous improvement of regulatory processes, tools, and templates to improve quality, efficiency, and compliance.

Other Duties

Represent Regulatory Affairs in internal leadership meetings, project governance discussions, audits, inspections, and external regulatory engagements.
Support business development, partnership, investor, or commercial activities by providing regulatory input as requested.
Participate as an integral member of the Cleveland Diagnostics Senior Leadership Team (SLT)
Perform other duties as assigned.

Qualifications/Requirements

Minimum of 10 years of progressive regulatory affairs experience in the medical device, diagnostics, or IVD industry.
Significant experience with FDA-regulated IVD products required.
Demonstrated leadership experience with FDA submissions, including PMAs, PMA supplements, amendments, annual reports, 510(k)s, pre-submissions, and responses to FDA questions.
Experience with blood-based diagnostics, oncology diagnostics, laboratory-developed tests, companion diagnostics, and early cancer detection products preferred.
Experience with IVDR Technical Documentation, Notified Body interactions, and international regulatory submissions preferred.
Prior experience leading regulatory strategy for product development, clinical validation, analytical validation, design changes, manufacturing changes, and post-market compliance.
Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred.
Experience supporting FDA inspections, audits, quality system activities, complaint evaluations, vigilance reporting, or post-market surveillance preferred.

Knowledge, Skills, and Abilities

Deep working knowledge of applicable regulatory frameworks, including FDA medical device and IVD regulations, PMA requirements, 510(k) requirements, 21 CFR 820/QMSR, ISO 13485, CLIA, IVDR, and relevant FDA guidance documents.
Strong strategic judgment and ability to advise executive leadership on regulatory risks, options, timelines, and business implications.
Excellent technical writing, editing, and regulatory submission review skills.
Ability to critically assess scientific, clinical, analytical, quality, manufacturing, and technical documentation.
Strong leadership, communication, negotiation, and cross-functional collaboration skills.
Ability to manage multiple complex regulatory programs, competing priorities, and time-sensitive deliverables, and regulatory affairs program budgets/KPIs
Exceptional attention to detail and strong document management, version control, and regulatory records discipline.
Advanced proficiency with Microsoft Word & Excel, and complex document formatting, including templates, styles, tracked changes, tables of contents, cross-references, and large technical documents.
Ability to operate effectively in a growing, fast-paced organization with hands-on involvement as needed.

Physical Requirements

Offices are reachable by elevator; must be able to climb stairs in the event elevator access is unavailable. General office and HVAC noise & fluorescent and/or LED lighting
Ability to sit and/or stand and operate a computer and other technology-related equipment throughout the workday.
May occasionally enter laboratory or manufacturing areas and may be exposed to hazardous chemicals, biohazards, or related controlled environments, subject to applicable safety procedures.

Other Requirements

This may be a hybrid position however Cleveland area candidates are preferred
Occasional travel may be required for regulatory meetings, audits, inspections, conferences, partner meetings, or other business needs.
Must be able to maintain confidentiality of proprietary, clinical, regulatory, and business-sensitive information.

Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics.

We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee's well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.

Cleveland Diagnostics offers an extremely robust benefits package which includes:

100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
100% Employer-paid Dental & Vision for entire family
No cost for employee coverage for Group Term Life, Short & Long Term Disability
4% retirement contribution Employer match
Incentive Performance Plan & Stock Option Program & Commission program
Generous PTO plan & holiday program
Flexible work schedule & lucrative employee referral program
Salary may vary by work state/geographical region/territory
Easy to get to office location with newly built-out office space
Free coffee, snacks and other goodies all day long

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company's status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.

Compensation details: 125000-225000 Yearly Salary

PI765bc6bda96f-25404-41279821

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Refine Your Search

senior chemical process jobs in cleveland, oh

Senior Director of Regulatory Affairs

Process Excellence Consultant / Manager / Senior Manager

Senior Product Development Chemist

Senior Process Innovation Chemist

EHS Senior Specialist

Sr. Nondestructive Test Technician

Senior Analyst, Mergers & Acquisitions

Global Change Management Leader, Customer Experience CoE

Crisis Response Specialist

Senior Process Engineer

City of Shaker Heights – Senior Housing Inspector

Director, Remote Operations Control Center

Senior Director, Global Gas Technology

Sr. Scientist I - Beachwood, OH

Senior Housing Inspector

Senior Research Assistant 1

Senior Health, Safety & Environmental Specialist

Senior Production Manager

Senior Sourcing Specialist - ESG

Powder Coatings Chemist

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