- 100% top-tier employee-paid health, dental, and vision insurance
- 401(k) with 3.5% company match
- Flexible work environment with strong work/life balance
- 20 days PTO + 5 sick days
- Inclusive, collaborative, and equity-focused workplace
- Low-micromanagement, results-driven culture
- Career growth within a growing organization
- Bachelor's degree in Engineering (Biomedical), Life Sciences, Regulatory Affairs, or related field
- 3–5 years of experience in medical device regulatory affairs
- Working knowledge of FDA 21 CFR, ISO 13485, EU MDR, and design controls
- Experience supporting US and international regulatory submissions
- Strong technical writing and documentation skills
- High attention to detail and strong organizational abilities
- Comfortable working independently in a fast-paced environment
- Experience with cardiovascular or implantable devices preferred
- Familiarity with export/import regulations and eQMS systems is a plus
- Support regulatory pathways for new product introductions and design changes
- Assist in preparing and organizing US and international regulatory submissions
- Contribute to filing strategies, testing requirements, and standards alignment
- Maintain regulatory records, procedures, and submission archives
- Support compliance with FDA, ISO, and international regulations
- Assist with product registrations, renewals, and regulatory commitments
- Partner with Engineering, Quality, Manufacturing, and R&D to gather technical documentation
- Participate in design reviews and risk management activities
- Provide regulatory input on labeling, testing, and change management
- Support internal and external audits and regulatory inspections
- Assist with inspection preparation and agency responses
- Monitor regulatory changes and communicate potential impacts
- Support export and import compliance requirements
- Help resolve regulatory challenges using compliant, practical solutions
- Contribute to the continuous improvement of regulatory systems and workflows
-
Regulatory Affairs Specialist
18 hours ago
Only for registered members Brecksville Full timeThis position is responsible for preparing submissions to various regulatory agencies. Additionally, the position will help maintain and improve upon domestic and international compliance. · ...
-
Lead Regulatory Affairs Specialist
1 week ago
Only for registered members Cuyahoga FallsCOLTENE is a global leader in the development, manufacture and sale of consumables and small equipment for dental treatment applications. · We are looking for the Lead Regulatory Affairs Specialist to join our Regulatory department at the Cuyahoga Falls, OH location. · The job in ...
-
Lead Regulatory Affairs Specialist
1 week ago
Only for registered members Cuyahoga Falls, OHWe are looking for the Lead Regulatory Affairs Specialist to join our Regulatory department at the Cuyahoga Falls, OH location. · The Lead Regulatory Affairs Specialist shall support the product portfolio, manufacturing operations, customer needs and P & L objectives of COLTENE b ...
-
Student Affairs Coordinator
12 hours ago
Only for registered members ClevelandThe Student Affairs Coordinator coordinates student affairs programs to build and maintain student satisfaction and retention in the Case School of Engineering departments. The position involves administrative assistance and support for students' interactions with and progress th ...
-
Director of Equity
1 month ago
Only for registered members Cleveland $65,779 - $83,210 (USD)The Director of Equity assists the Vice President in overseeing Case Western Reserve University compliance with equal employment opportunity and civil rights laws. · Maintain a case load and thoroughly investigates internal complaints of discrimination and harassment. · Prepare i ...
-
Doctor of Medicine
1 month ago
Only for registered members ClevelandWe are seeking a dedicated Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (OD) to join our team in Cleveland, OH. As an integral part of our team, you will provide basic and specialized medical care to a diverse range of patients. · Maintain a clear line of communicati ...
-
Director of Human Resources
1 month ago
Only for registered members ClevelandThis is a unique opportunity for an HR leader who wants to make a meaningful impact in a mission-driven environment. · Lead day-to-day HR operations. Partner with leadership to ensure HR practices reflect CIA's mission. · ...
- Only for registered members Cleveland $188,700 - $228,660 (USD)
Bristol Myers Squibb has a rich history in Neuroscience focused on developing innovative medicines to help people living with Neurodegenerative and Neuromuscular conditions.The DBM will be responsible for building and leading a team of 7-9 Mental Health Account Specialists hired ...
-
Industry Reporting and Communications Specialist
3 weeks ago
Only for registered members Cleveland+We are seeking an Industry Reporting and Communications Specialist to help advance our mission of promoting grid reliability and security. · +Draft, edit, and format critical reliability reports · Analyze and summarize industry data for clear communication · Develop high-impact ...
-
Doctor of Medicine
1 week ago
Only for registered members East Blvd Cleveland, Ohio, United States+Job summary · We deliver medical examination-only services to public sectors and individuals they serve. · +ResponsibilitiesProvide basic and specialized medical care to diverse range of patients. · ...
-
Critical Care Specialist
3 days ago
Only for registered members Cleveland $105,000 - $125,000 (USD)The Critical Care Specialist – Blood Gas is responsible for driving sales growth of Nova Biomedical Critical Care analyzers across assigned hospital and health system accounts.This role is accountable for revenue growth, penetration of key accounts, and expansion of Nova's blood ...
-
Critical Care Specialist
1 day ago
Only for registered members Cleveland $105,000 - $125,000 (USD)The Critical Care Specialist – Blood Gas is responsible for driving sales growth of Nova Biomedical Critical Care analyzers across assigned hospital and health system accounts. · This role is accountable for revenue growth, penetration of key accounts, and expansion of Nova's blo ...
-
Physician (SICU Chief)
1 week ago
Only for registered members ClevelandThe Louis Stokes Cleveland VA Medical Center seeks a full-time Board Certified SICU Physician in the Surgical and Perioperative Care Service Line at the Louis Stokes Cleveland VAMC.This position is eligible for the Education Debt Reduction Program (EDRP) - a student loan payment ...
-
Rare Disease Sales Specialist
22 hours ago
Inizio Engage ClevelandWe are seeking a performance-driven Rare Disease Sales Specialists who is passionate about making a difference in healthcare. · This role is responsible for managing all aspects of territory business development, cultivating relationships within key targets, · driving disease awa ...
-
PRN Advanced Certified Medication Aide/PCA III
1 month ago
Only for registered members Cleveland County Part timePart-time Certified Medication Aide/PCA III position available at Norman Veterans Home in Cleveland County, OK. Job requires providing direct and indirect non-professional nursing care or outreach services under nursing or medical supervision. · ...
-
prn lpn iii
2 weeks ago
Only for registered members Cleveland County Part timeThis position involves performing technical direct and indirect nursing care in a clinic setting for individuals under supervision or direction of a registered nurse, licensed physician, or dentist. · Taking temperatures, pulse, respiration and blood pressure; · Giving enemas; do ...
-
Tank Permitting Specialist
2 days ago
Only for registered members Cleveland, OHWe're looking for a detail-oriented Permitting Specialist to manage the Above Ground Storage Tank (AST) permitting across each jurisdictions in which Great Lakes Petroleum currently operates. · This role will ensure compliance with environmental, fire code, and regulatory standa ...
- Only for registered members Cleveland
We are seeking a highly motivated and strategic Sales Representative to join our Immunology team.This individual will be responsible for promoting and selling our innovative therapies to healthcare providers within a designated territory. · ...
-
Rare Disease Sales Specialist
5 days ago
Inizio Engage Cleveland Full timeWe are seeking a performance-driven Rare Disease Sales Specialist who is passionate about making a difference in healthcare. · This role requires strong clinical and disease state knowledge to manage all aspects of territory business development, · cultivate relationships within ...
-
Industry Reporting and Communications Specialist
3 weeks ago
Only for registered members Cleveland, OH+About RF: · ReliabilityFirst Corporation is focused on preserving and enhancing reliability, security, · and resilience of the Bulk Power System across 13 states and the District of Columbia.+Draft, edit, · and format critical reliability reports, · Analyze and summarize industr ...
Medical Device Regulatory Affairs Specialist - Cleveland - Goodwin Recruiting
Description
***This job is in Pittsburgh***
We are seeking a driven, detail-oriented Regulatory Affairs Specialist to join our growing medical device team and support regulatory submissions, compliance initiatives, and full product lifecycle management for implantable cardiovascular devices. This is a hands-on role for a motivated professional who excels in highly regulated environments, collaborates effectively across technical and clinical teams, and takes true ownership of their work. If you have a strong working knowledge of FDA and international regulatory requirements and are looking to build a long-term career in Regulatory Affairs, we encourage you to apply.
Regulatory Affairs Specialist Benefits
Regulatory Affairs Specialist Qualifications
Regulatory Affairs Specialist Responsibilities Include
-
Regulatory Affairs Specialist
Full time Only for registered members Brecksville
-
Lead Regulatory Affairs Specialist
Only for registered members Cuyahoga Falls
-
Lead Regulatory Affairs Specialist
Only for registered members Cuyahoga Falls, OH
-
Student Affairs Coordinator
Only for registered members Cleveland
-
Director of Equity
Only for registered members Cleveland
-
Doctor of Medicine
Only for registered members Cleveland
-
Director of Human Resources
Only for registered members Cleveland
-
Executive District Business Manager, Mental Health Account Specialists
Only for registered members Cleveland
-
Industry Reporting and Communications Specialist
Only for registered members Cleveland
-
Doctor of Medicine
Only for registered members East Blvd Cleveland, Ohio, United States
-
Critical Care Specialist
Only for registered members Cleveland
-
Critical Care Specialist
Only for registered members Cleveland
-
Physician (SICU Chief)
Only for registered members Cleveland
-
Rare Disease Sales Specialist
Inizio Engage- Cleveland
-
PRN Advanced Certified Medication Aide/PCA III
Part time Only for registered members Cleveland County
-
prn lpn iii
Part time Only for registered members Cleveland County
-
Tank Permitting Specialist
Only for registered members Cleveland, OH
-
Immunology Therapeutic Specialist, Cleveland OH/ Detroit, MI
Only for registered members Cleveland
-
Rare Disease Sales Specialist
Full time Inizio Engage- Cleveland
-
Industry Reporting and Communications Specialist
Only for registered members Cleveland, OH