Senior Manager, Regulatory Affairs (Hybrid) (Dublin, OH)

POSITION: Senior Manager, Regulatory Affairs

FULL-TIME/PART-TIME: Full Time

LOCATION: Dublin, OH (Hybrid)

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.

GENERAL SUMMARY

Responsible for leading the day-to-day regulatory pre-market and post-market activities which include team oversight, regulatory strategy guidance, and hands-on submission or other regulatory responsibilities. Responsible for resourcing, leadership, and employee coaching & development.

QUALIFICATIONS

A minimum of a bachelor’s degree is required.

A minimum of 10 years of experience in regulatory affairs in the Medical Device industry and a minimum of 2 years of experience in people management.

Demonstrated ability to lead and manage others, either through projects or direct management.

Demonstrated success in regulatory submissions activities, such as 510(k), and international registrations.

Strong understanding of FDA regulations and ISO standards required.

Oversee the preparation and maintenance of regulatory documentation, including Technical Files, Design Dossiers, and Device Master Records.

Ensure that all documents meet regulatory requirements and are up to date.

Ability to effectively partner cross-functionally to develop and influence sound regulatory strategies.

Ability to successfully manage multiple projects simultaneously and prioritize individual and team assignments to meet business needs.

Excellent written and oral communication, technical writing, and editing skills.

Strong leadership, interpersonal, and influencing skills.

Ability to work independently and prioritize workload with minimal supervision.

Provide guidance, training, and development opportunities to team members.

Proficient with Microsoft Office suite.

This role may work remotely with 25% of travel required.

Preferred Education

Advanced degree in scientific/engineering/biomedical field with at least 10 years of experience in Regulatory Affairs.

Preferred Experience

Regulatory Affairs Certification for Medical Devices

Knowledge of Sleep, Ventilation and Oxygen product portfolio is preferred.

Understanding and experience with global regulatory submissions

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.

Physical Demands

Requires normal visual acuity and hearing.

Typically, employees sit comfortably to do their work, interspersed by brief periods of standing, walking, bending, carrying papers and books, and extensive periods requiring the use of computer terminals to accomplish work objectives.

Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.

Additional skills may be required to perform additional task(s) specific to work location, department or line of business.

Working Conditions

Predominantly operates in an office environment. Some work (less than 5%) requires moving and lifting of heavy networking equipment.

DUTIES AND ESSENTIAL FUNCTIONS

Each Employee consistently demonstrates the following essential functions:

Provides regulatory expertise with respect to global regulatory strategy development, execution, and risk management.

Provides advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes.

Establishes and manages project priorities, allocating resources and workload to achieve business milestones.

Participates in outreach with senior functional leaders to achieve business objectives and assess commercialization pathway trade-offs.

Provides regulatory expertise to facilitate entry into new technologies and design.

Drives clarity into product approval and post market requirements through effective problem identification, communication, and use of regulatory agency network.

Operates effectively as regulatory team lead on assigned projects including global regulatory strategy development and execution.

Capable of authoring and executing / supporting all aspects of Global Regulatory Strategies and submissions. Provides regulatory expertise and assessment for product and manufacturing changes.

Prepare teams for and lead FDA and Health Authority meetings

Supports New Business Development by performing regulatory due diligence on candidate companies and products; provides initial regulatory project management for integration of new companies and products into the business; assesses RA resource needs and supports staffing and new employee integration as needed.

Studies and understands applicability of relevant regulations to the business.

Provides regulatory intelligence guidance to the business. Research competitive product regulatory approvals and pathways and disseminates to stakeholders.

Supports Quality System and audit readiness through maintenance and provision of regulatory information to QA, Notified Bodies / Registrars and FDA.

Attends and participates in departmental meetings, seminars and training sessions necessary to maintain appropriate level of professional competence

Directs and coordinates activities of Regulatory Affairs team.

Leads regulatory-related education efforts and mentoring in areas of expertise.

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

Reasonable accommodations may be made to accommodate individuals with disabilities to perform the basic functions of the position without compromising client 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 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.