- General Responsible for compliance of Quality System regarding ISO Standard 13485 alignment with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), FDA and other applicable requirements, laws, and standards.
- Responsible for the management of the Regulatory Affairs Processes, Registration, Non-Conformities, Product Recalls, and Medical Device Reporting (EUMDR). Act as Person Responsible for Regulatory Compliance (PRRC).
- Maintain an effective quality management system (QMS) to ensure the consistent delivery of high-quality products.
- Define and monitor key quality performance metrics, ensuring continuous improvement in product quality.
- In charge of HIPAA-related activities, including Privacy Officer training for associates on updated and enhanced quality system procedures and instructions
- Overseeing Vigilance and Post-Market Surveillance activities
- Leads and guides the quality and regulatory team, offering coaching to the purchasing staff and fostering collaboration between inspection personnel and other departments.
- Manages staff selection, performance, development, and training to ensure team competencies align with business goals.
- Identifies department training needs and develops materials to support company objectives.
- Responsible for the quality interests and concerns of projects – assisting design controls (Design Inputs/Outputs, Design Verification and Validation, Design, and Process Risk Management – DFMEA/PFMEA, Design Master Record, Design History Files, etc.)
- Expertise in validation, verification, and usability processes for new and improved products.
- Responsible for the System Computer Software Validation in compliance of the standards and regulations.
- Establishes and maintains the Company's System Procedures for regulatory compliance.
- Manages incident reporting and adverse event recalls.
- Responsible for Establishment Registration & Device Listing of class I and II Medical Devices
- Oversees Risk Management for Medical Devices according to ISO 14971
- Promotes the development of Quality Competencies and Quality Awareness throughout the organization.
- Bachelor's degree in a relevant field or Engineering; advanced degree preferred with greater than 10 years of experience in the creation and Management of Quality Systems.
- 3+ years of related experience in the Medical Device FDA-regulated industry to include product/process validation and solving technical problems.
- Experience working as a Quality Engineer or Manager in a manufacturing environment Competent in FDA QSR, ISO 13485, and ISO9001, ISO14971, & EUMDR requirements.
- Strong knowledge of FDA regulations and international regulatory requirements.
- Excellent leadership and team management skills.
- Strong analytical and problem-solving abilities.
- Demonstrated ability to work collaboratively across departments.
- Skilled auditor with knowledge of FDA, ISO13485, and EUMDR requirements.
- Ability to read and interpret drawings and design specifications.
- Proficient in technical writing skills and communications.
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Regulatory Affairs Specialist
1 week ago
AtriCure, Inc. Cincinnati, United States Regular, Full time· Regulatory Affairs Specialist · Cincinnati, OH, USA * Mason, OH, USA * Minneapolis, MN, USA * Minnetonka, MN, USA · Req #2095 · Wednesday, May 22, 2024 · AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 ...
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Regulatory Affairs Specialist
1 week ago
AtriCure, Inc. Cincinnati, United States Regular, Full time· Regulatory Affairs Specialist · Cincinnati, OH, USA * Mason, OH, USA * Minneapolis, MN, USA * Minnetonka, MN, USA · Req #2100 · Wednesday, May 29, 2024 · AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 ...
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Experienced Regulatory Affairs Specialist
1 week ago
Medpace Cincinnati, United StatesJob Summary: · Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Operations Associate to join our Regulatory Affairs team in Cincinnati. This position will work on a team to accomplish tasks and projects that are inst ...
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Experienced Regulatory Affairs Specialist
3 weeks ago
Medpace Cincinnati, United StatesJob Summary: · Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Operations Associate to join our Regulatory Affairs team in Cincinnati. This position will work on a team to accomplish tasks and projects that are inst ...
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Specialist - Regulatory Affairs - Allergy
3 weeks ago
Cincinnati Children's Hospital Cincinnati, United StatesSUBFUNCTION DEFINITION: Ensure CCHMC is meeting all regulatory requirements, policies and procedures. Identifies and mitigates risks. · CCHMC SALARY GRADE:9 · REPRESENTATIVE RESPONSIBILITIES · * Protocol · Apply a comprehensive understanding of research reProtocolgulations, e ...
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Specialist - Regulatory Affairs - Allergy
3 weeks ago
Cincinnati Children's Hospital Cincinnati, United StatesSUBFUNCTION DEFINITION: Ensure CCHMC is meeting all regulatory requirements, policies and procedures. Identifies and mitigates risks.CCHMC SALARY GRADE:9REPRESENTATIVE RESPONSIBILITIES* ProtocolApply a comprehensive understanding of research reProtocolgulations, ethics and guidel ...
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Specialist - Regulatory Affairs - Allergy
3 weeks ago
cchmc Cincinnati, United States: · SUBFUNCTION DEFINITION: · Ensure CCHMC is meeting all regulatory requirements, policies and procedures. Identifies and mitigates risks. · CCHMC SALARY GRADE: 9 · REPRESENTATIVE RESPONSIBILITIES · Protocol · Apply a comprehensive understanding of research reProtocolgulations ...
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Senior Regulatory Affairs Program Lead
2 weeks ago
J&J Family of Companies Cincinnati, United StatesSenior Regulatory Affairs Program Lead W · Description · Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Regulatory Affairs Program Lead , to be located in Cincinnati, Ohio; Raynham, MA; Raritan, NJ or Santa Clara, CA. · At Jo ...
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Gateway Recruiting Cincinnati, United StatesSUMMARY: · The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR). This position reports to the US CEO and indirectly to the Group Director of Quality Manageme ...
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Gateway Recruiting, INC. Cincinnati, United StatesJob Description · Job DescriptionSUMMARY: · The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR). This position reports to the US CEO and indirectly to the Gr ...
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Regulatory Affairs Specialist
1 week ago
AtriCure Mason, United StatesAtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reductio ...
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Cincinnati Children's Hospital Medical Center Cincinnati, United States Full timeSpecialist - Regulatory Affairs - OCTR - Previous CRC lll experience a plus & monitoring/auditing human subjects Description Main job responsibility: Conducting monitoring visits for investigator initiated, single and multi-site studies. · Required: experience in conducting cl ...
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University of Cincinnati Cincinnati, United StatesCurrent UC employees must apply internally via SuccessFactors > · Founded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to more than 50,000 students, 11,000 faculty and staff and 340,000 alumni, UC combines a Top 35 ...
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University of Cincinnati Cincinnati, United States OTHERCurrent UC employees must apply internally via SuccessFactors > · Founded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to more than 50,000 students, 11,000 faculty and staff and 340,000 alumni, UC combines a Top 3 ...
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Gateway Recruiting Union, United StatesSUMMARY:The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR). This position reports to the US CEO and indirectly to the Group Director of Quality Management a ...
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Fruit Inspector
1 week ago
WV Department of Agriculture Inwood, United StatesWest Virginia Department of Agriculture · Position Description · - ____________________________________________________________________ · **Job Title**: Fruit Inspector · **Division**: Business Development · **Headquarters**: Inwood, WV · **Reports To**: Program Manager & Assista ...
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Fund Compliance Legal Analyst
4 weeks ago
Ohio National Financial Services Cincinnati, United States Full timeJob Description · At the Constellation Insurance family of companies, we are committed to fostering a workplace where diversity, inclusivity and equity are celebrated. · If you're passionate about our mission but don't perfectly fit every requirement, we encourage you to apply ...
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InsideHigherEd Cincinnati, United StatesCurrent UC employees must apply internally via SuccessFactors > Founded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to over 50,000 students, 11,000 faculty and staff and 332,000 alumni, UC combines a Top 35 public ...
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VP, Health Systems
6 days ago
Synchrony Cincinnati, United StatesJob ID: E2402198 · Job Description: · Role Summary/Purpose: · Reporting to SVP & GM – Wellness, the VP Health Systems will lead a high-performance team focused on building long-term successful relationships with assigned Health Systems as well as individually manage and own one o ...
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North American Regulatory Expert
1 week ago
Medpace Cincinnati, United StatesJob Summary: · Our clinical activities are growing rapidly, and we are currently seeking a full-time, Cincinnati-based Regulatory Expert to join our team. This position is responsible for the interactions with FDA, accountable for the development and implementation of the regula ...
Director Quality Assurance and Regulatory Affairs - Cincinnati, United States - Gateway Recruiting - Gateway to Global Careers - Contingent, Retained, Contract Recruiting Services
Description
SUMMARY:
The Director of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR). This position reports to the US CEO and indirectly to the Group Director of Quality Management and Regulatory Affairs.
This role encompasses a wide range of responsibilities, including the development and implementation of quality system procedures, training associates on updated procedures, overseeing the Corrective and Preventive Action process (CAPA), evaluating product and process non-conformances, and providing support to production and inspection teams in addressing quality-related challenges.
The director demonstrates excellence in cross-functional collaboration and effectively collaborates with teams at all organizational levels. Together, we are committed to upholding the highest standards of product quality and regulatory compliance.
ESSENTIAL FUNCTIONS:
KNOWLEDGE, SKILLS, AND ABILITIES:
Director Quality Assurance and Regulatory Affairs professionals in Cincinnati
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Sanjay Rathore
Medical Director