React Health
Senior, Regulatory Affairs Specialist (Remote)
React Health, Dublin, Ohio, United States, 43016
Overview
Join to apply for the
Senior, Regulatory Affairs Specialist (Remote)
role at
React Health . POSITION:
Senior Regulatory Affairs Specialist FULL-TIME: Full Time LOCATION: Remote React Health is a fast-paced, growth-driven manufacturer and distributor of medical equipment, dedicated to supporting patients, caregivers, physicians, and healthcare providers. With a focus on respiratory and sleep health sectors, we offer a comprehensive range of products and services across acute care, non-acute care, and home medical equipment. By integrating manufacturing and distribution, React Health addresses the needs of both undiagnosed individuals and those requiring therapy after diagnosis, particularly within the sleep and respiratory care sectors.
Responsibilities
Lead and execute global regulatory strategies for development programs and marketed products, including labeling and promotional materials.
Support health authority communications and participate in regulatory strategy development.
Maintain a strong collaborative partnership with cross-functional teams to protect patient/user safety and meet business needs.
Prepare and maintain regulatory submissions, maintain 510(k) and international product registrations.
Review and approve design/manufacturing changes and analyze their impact on regulatory filings.
Maintain current standards lists and lead projects to achieve compliance with latest standards.
Monitor regulatory environment and provide updates in management reviews; serve as primary point of contact for regulatory agency interactions.
Participate in inspections and audits as needed; manage recall administrations as required.
Ensure conformance with applicable regulations and guidance documents in product development, claims support, labeling, and promotional materials.
Stay current on international regulatory requirements and lead regulatory approvals accordingly.
Support maintaining a cGMP-compliant Quality Management System in line with FDA 21 CFR 820, cGMP, and other international requirements.
Develop regulatory processes and work instructions as necessary; lead audit readiness initiatives and investigate issues related to product, process, or Quality System.
Participate in department meetings, training, and ongoing professional development; provide customer-focused interactions.
Qualifications
Bachelor’s degree in engineering or life science discipline.
Minimum 7 years of regulatory affairs experience in the medical device industry.
Strong understanding of ISO 13485, FDA 21 CFR Part 820 and other international regulatory requirements.
Strong understanding of statistical techniques.
Regulatory Affairs Certification (RAC) highly preferred.
Excellent communication and documentation skills; strong organization and attention to detail.
Preferred education: Master’s degree in engineering or life science discipline, or equivalent experience.
Preferred Experience
Excellent attention to detail and project management skills.
Strong written and oral communication skills; ability to work effectively with diverse groups.
Physical Demands
Requires normal visual acuity and hearing.
Typically seated with periods of standing, walking, bending, and extensive computer use.
Frequent keyboard use and manual dexterity required.
Working Conditions
Predominantly office environment; occasional moving and lifting of equipment.
Duties And Essential Functions
Prepare and maintain regulatory submissions; maintain 510(k) and international registrations.
Review and approve design/manufacturing changes; assess regulatory impact.
Lead regulatory intelligence, monitor regulatory environment, and provide updates to management.
Serve as primary contact for regulatory agencies; participate in inspections and audits.
Lead recall administration and ensure timely communication of regulatory issues.
Guide conformance with regulations in product development, claims, labeling, and promotional materials.
Maintain knowledge of international regulatory requirements and lead approvals as appropriate.
Support cGMP Quality Management System compliance and related regulatory requirements.
Develop processes and work instructions; support audit readiness and issue investigations.
Attend meetings and training as delegated; provide customer-focused interactions.
Perform other duties as delegated within department scope.
Reasonable accommodations may be made to accommodate individuals with disabilities to perform the basic functions of the position without compromising patient care. React Health is an Equal Opportunity/Affirmative Action Employer and is committed to providing a drug-free workplace. We are an Equal-Opportunity Employer and do not discriminate against any applicant or employee because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, disability, or any other protected class.
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Join to apply for the
Senior, Regulatory Affairs Specialist (Remote)
role at
React Health . POSITION:
Senior Regulatory Affairs Specialist FULL-TIME: Full Time LOCATION: Remote React Health is a fast-paced, growth-driven manufacturer and distributor of medical equipment, dedicated to supporting patients, caregivers, physicians, and healthcare providers. With a focus on respiratory and sleep health sectors, we offer a comprehensive range of products and services across acute care, non-acute care, and home medical equipment. By integrating manufacturing and distribution, React Health addresses the needs of both undiagnosed individuals and those requiring therapy after diagnosis, particularly within the sleep and respiratory care sectors.
Responsibilities
Lead and execute global regulatory strategies for development programs and marketed products, including labeling and promotional materials.
Support health authority communications and participate in regulatory strategy development.
Maintain a strong collaborative partnership with cross-functional teams to protect patient/user safety and meet business needs.
Prepare and maintain regulatory submissions, maintain 510(k) and international product registrations.
Review and approve design/manufacturing changes and analyze their impact on regulatory filings.
Maintain current standards lists and lead projects to achieve compliance with latest standards.
Monitor regulatory environment and provide updates in management reviews; serve as primary point of contact for regulatory agency interactions.
Participate in inspections and audits as needed; manage recall administrations as required.
Ensure conformance with applicable regulations and guidance documents in product development, claims support, labeling, and promotional materials.
Stay current on international regulatory requirements and lead regulatory approvals accordingly.
Support maintaining a cGMP-compliant Quality Management System in line with FDA 21 CFR 820, cGMP, and other international requirements.
Develop regulatory processes and work instructions as necessary; lead audit readiness initiatives and investigate issues related to product, process, or Quality System.
Participate in department meetings, training, and ongoing professional development; provide customer-focused interactions.
Qualifications
Bachelor’s degree in engineering or life science discipline.
Minimum 7 years of regulatory affairs experience in the medical device industry.
Strong understanding of ISO 13485, FDA 21 CFR Part 820 and other international regulatory requirements.
Strong understanding of statistical techniques.
Regulatory Affairs Certification (RAC) highly preferred.
Excellent communication and documentation skills; strong organization and attention to detail.
Preferred education: Master’s degree in engineering or life science discipline, or equivalent experience.
Preferred Experience
Excellent attention to detail and project management skills.
Strong written and oral communication skills; ability to work effectively with diverse groups.
Physical Demands
Requires normal visual acuity and hearing.
Typically seated with periods of standing, walking, bending, and extensive computer use.
Frequent keyboard use and manual dexterity required.
Working Conditions
Predominantly office environment; occasional moving and lifting of equipment.
Duties And Essential Functions
Prepare and maintain regulatory submissions; maintain 510(k) and international registrations.
Review and approve design/manufacturing changes; assess regulatory impact.
Lead regulatory intelligence, monitor regulatory environment, and provide updates to management.
Serve as primary contact for regulatory agencies; participate in inspections and audits.
Lead recall administration and ensure timely communication of regulatory issues.
Guide conformance with regulations in product development, claims, labeling, and promotional materials.
Maintain knowledge of international regulatory requirements and lead approvals as appropriate.
Support cGMP Quality Management System compliance and related regulatory requirements.
Develop processes and work instructions; support audit readiness and issue investigations.
Attend meetings and training as delegated; provide customer-focused interactions.
Perform other duties as delegated within department scope.
Reasonable accommodations may be made to accommodate individuals with disabilities to perform the basic functions of the position without compromising patient care. React Health is an Equal Opportunity/Affirmative Action Employer and is committed to providing a drug-free workplace. We are an Equal-Opportunity Employer and do not discriminate against any applicant or employee because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, disability, or any other protected class.
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