Principal Regulatory Affairs Specialist

Tired of working at a "good" job?

• The Principal Regulatory Affairs Specialist serves as the highest-level individual contributor within Regulatory Affairs and is responsible for developing and executing global regulatory strategies that support product development, registration, commercialization, market expansion, and lifecycle management of Elevaris products. This role provides advanced regulatory leadership for complex projects, serves as a key subject matter expert on U.S., EU, and international regulatory requirements, and partners closely with cross-functional teams to ensure regulatory objectives align with business priorities.
• The position independently leads complex submissions, drives regulatory strategy, assesses regulatory risk, supports agency interactions, and mentors Regulatory Affairs team members while ensuring ongoing compliance with applicable global regulations.

• →Develop and lead regulatory strategies supporting new product development, product modifications, market expansion, and lifecycle management
• →Serve as the primary regulatory affairs representative on cross-functional product development teams.
• →Provide regulatory guidance and risk assessments related to design, manufacturing, supplier, and labeling changes
• →Lead preparation and submission of 510(k)s, PMAs, IDEs, international registrations, renewals, and regulatory assessments
• →Coordinate responses to regulatory agency requests and represent regulatory perspectives with FDA, Notified Bodies, and global authorities
• →Review and approve engineering changes, labeling, IFUs, promotional materials, and development documentation
• →Develop and maintain Technical Files, Design History Files, and regulatory dossiers
• →Monitor emerging regulations and assess business impact
• →Provide technical mentorship and leadership to Regulatory Affairs team members

• Independently make regulatory decisions within established frameworks
• Recommend regulatory strategies and risk mitigation approaches for complex projects
• Collaborate with Quality, R&D, Clinical Affairs, Manufacturing, Supply Chain, Marketing, and Commercial teams

• Regulatory submissions are completed accurately and on schedule
• Products remain compliant with global regulations
• Regulatory risks are proactively identified and mitigated
• Regulatory strategies support business growth and innovation 

• Bachelor’s degree in a scientific discipline required; advanced degree preferred
• 8+ years of progressive Regulatory Affairs experience in medical devices
• Experience leading FDA submissions including 510(k)s
• Advanced knowledge of FDA, EU MDR, ISO 13485, and global regulatory requirements
• Strong project leadership, communication, and risk assessment skills

• RAC certification 

The physical demands described here are representative of those required to successfully perform the essential functions of this role. Reasonable accommodation may be made in accordance with applicable local laws. Contact your manager or HR to understand the work conditions and physical requirements that may be specific to your role.

·         10-15% domestic and international travel as required

·         Regular use of computer and communication tools

·         Ability to work independently and/or in a team environment

·         Additional requirements may vary by role and location

At Elevaris, what we accomplish matters — and so does how we accomplish it. Every employee is expected to demonstrate our Values of Integrity, Invested, Inclusion and Ingenuity through their everyday decisions, behaviors and interactions.

 Elevaris is committed to providing equal employment opportunities in all locations where we operate. We do not discriminate on the basis of any characteristic protected by applicable local laws.

An Equal Opportunity Employer/Contractor: Elevaris believes that all persons are entitled to equal employment opportunity. The Company will not discriminate or tolerate discrimination against any employee or applicant because of race, color, creed, religion, genetic information, sex, sexual orientation, national origin, age, status with regard to public assistance, marital or veteran status, disability or any other characteristic protected by local, state or federal law. Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination. Disabled applicants may request any reasonable accommodation needed to enable them to complete the application process.