Senior, Regulatory Affairs Specialist (Remote)

React Health; Kentucky; Remote; USD 80,000 - 100,000; Full time

Job summary

A healthcare solutions provider in Kentucky is seeking a Senior Regulatory Affairs Specialist (Remote) to lead the regulatory strategies for medical equipment. The ideal candidate has over 7 years of experience in the medical device industry and a strong understanding of regulatory standards. Responsibilities include managing submissions and maintaining compliance with FDA and international regulations. This role offers a dynamic work environment and requires excellent communication and project management skills.

Qualifications

• Minimum 7 years of RA experience in the medical device industry.
• Strong understanding of ISO 13485 and FDA regulations.
• Regulatory Affairs Certification (RAC) highly preferred.

Responsibilities

• Prepare and maintain regulatory submissions and registrations.
• Analyze product changes for impact to regulatory filings.
• Guides compliance with applicable regulations and guidance.

Skills

Regulatory Affairs

Communication skills

Attention to detail

Project management

Education

Bachelor’s degree in engineering or life science

Master’s degree in engineering or life science

Job description

Senior Regulatory Affairs Specialist (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.

The Senior Regulatory Affairs (RA) Specialist leads and executes global regulatory strategies for development programs and marketed products, labeling, ad promo areas. Additionally, this individual will support health authority communications and participate in regulatory strategy development. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Qualifications

• Bachelor’s degree in engineering or life science discipline
• Minimum 7 years of RA 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 skills

Preferred Education

• Master’s degree in engineering or life science discipline, or equivalent experience

Preferred Experience

• Excellent attention to detail and project management skills.
• Excellent written/oral communication skills required. Must be able to work effectively with diverse groups of people.

Duties And Essential Functions

• Prepare and maintain regulatory submissions, maintain 510k and international product registrations.
• Review and approve design/manufacturing changes. Analyze product changes for impact to current regulatory filings
• Maintain current standards list. Identify and lead projects to comply with latest standards
• Regulatory Intelligence: Monitor regulatory environment , Provide regulatory environment update in Management Reviews
• Primary point of contact for regulatory agency interactions. Participate in inspections and audits as needed.
• Recall administration
• Proactively identifies issues, effectively communicates timelines for project completion, and addresses issues that may impact registration status.
• Guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials.
• Stay current on international regulatory requirements and lead appropriately regulatory approvals.
• Support maintaining a cGMP compliant Quality Management System to ensure the Quality System is established and maintained in accordance with FDA 21 CFR 820, cGMP, (MDD 93/42/EEC, MDR 2017/745,),ISO 13485 and other international regulatory requirements.
• Develop relevant regulatory processes and work instructions as necessary.
• Lead audit readiness initiative. Investigate and document issues relating to the product, process, or Quality System relevant to the regulatory compliance.
• Attends and participates in departmental meetings. Attends seminars and training sessions necessary to maintain appropriate level of professional competence
• Attends all meetings, training, or continuing education as delegated by the supervisor
• Provides customer focused interactions
• Performs all duties necessary for the department as per department policies and procedures
• Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department

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 employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.