Job SummaryThe Senior Regulatory Affairs Program Specialist is responsible for leading the collaboration with cross-functional stakeholders to ensure regulatory compliance is met. The Senior Regulatory Affairs Program Specialist will act as the technical liaison between cross-functional departments and the Regulatory Affairs team.
Essential Functions- Evaluate and resolve regulatory and technical issues due to extensive knowledge of medical device manufacturing and related regulatory requirements in this product sector through a clear understanding of the product development lifecycle
- Lead technical medical device compliance initiatives, including assessing and communicating technical guidelines to support pre-market requirements
- Drive education of regulatory compliance to key business stakeholders
- Serve as the product technical subject matter expert for the Regulatory Regions teams to meet the requirements of regulatory bodies.
- Review global regulatory submissions for technical accuracy and regulatory compliance.
- Support technical inquiries for the medical device regulatory submissions, registrations, licenses, clearances, approvals, and deficiencies for global market entry.
- Initiate reviews of change requests and regulatory strategies for new product innovations or devices changes. Works collaboratively with the Regulatory Regions team to assess regulatory impact.
- Collaborate with Engineering and R&D to develop the standards strategy for medical devices and supports activities required to maintain regulatory compliance as new or revised versions of standards are released.
- Collaborate with R&D and Quality Assurance in the development of risk management plans and hazard analysis for ZOLL products.
- Collaborate with key stakeholders to ensure and improve efficiencies throughout design documentation in accordance with regulatory requirements and best practices
- Communicate clearly and effectively with cross-department personnel
- Participate in regulatory audits/inspections as required
- Author and maintain standard operating procedures (SOPs) and train key personnel as needed
Required/Preferred Education and Experience- Bachelor's Degree required
- 5+ years of regulatory experience in the Medical Device Industry required
- Previous experience working with Regulatory Authorities relative to premarket and compliance activities required
Knowledge, Skills and Abilities- Project management skills
- Must be able to work under pressure to meet regulatory reporting time frames and company requirements
- Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
- Experience interacting with FDA and/or other regulatory agencies
- Must work well in team environments
- Must demonstrate leadership skills in team setting
- Proven analytical abilities, able to apply problem-solving skills for problems of moderate to diverse scope
- Understanding of manufacturing and change control, and an awareness of regulatory trends
- Understanding of engineering concepts and scientific terminology
- Superior interpersonal skills
- Excellent communication skills, both oral and written
- Proven ability to prioritize, conduct, and manage time to meet project deadlines
- Documented evidence of writing skills
- Basic understanding of computer applications
- Strong understanding of medical terminology
Physical DemandsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Standing - Occasionally
- Walking - Occasionally
- Sitting - Constantly
- Talking - Occasionally
- Hearing - Occasionally
- Repetitive Motions - Frequently
The annual salary for this position is:
$105,000.00 to $125,000.00
This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location.
