Senior Regulatory Affairs Specialist

On-X Life Technologies, Inc.; Town of Texas, Austin (WI, TX); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Regulatory Affairs Specialist to join their dynamic team. This role involves developing regulatory strategies and managing submissions for innovative medical devices aimed at addressing cardiac and vascular conditions. The successful candidate will work independently on regulatory projects, collaborate with cross-functional teams, and provide guidance to junior staff. If you have a strong background in regulatory affairs and a passion for improving healthcare outcomes, this opportunity is perfect for you.

Qualifications

• 4+ years of regulatory experience or 2+ years with an advanced degree.
• Experience with FDA Class II or III devices is essential.

Responsibilities

• Develop regulatory strategies and submission activities for new products.
• Collaborate with global teams to maintain regulatory compliance.

Skills

Regulatory Strategy Development

FDA Class II/III Devices

Cross-Functional Team Collaboration

Analytical Skills

Technical Writing

Project Management

Communication Skills

Education

Bachelor's Degree in a Related Field

Advanced Degree (Preferred)

Job description

Description

Company Overview

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,600 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details on the On-X Mechanical Heart Valve, click here.

Position Objective:
The Senior Regulatory Affairs (RA) Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions, and obtaining and maintaining approval for products to markets worldwide. Additionally, the Sr. RA Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. The Sr. RA Specialist will work independently, manage their own regulatory projects, and provide guidance and support to junior staff.

Responsibilities:

• Define the regulatory strategies and submission activities (510(k), IDE, PMA, EU/CE Technical Documentation Files, Canadian License, international registrations, including amendments, supplements, renewals, annual reports and responses to requests for additional information) for complex new product development activities and product maintenance for existing approved products.


• Team with global partners and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with cross-functional teams and subject matter experts to maintain regulatory compliance and address questions from regulatory agencies.


• Review significant product submissions with project stakeholders and negotiate submission issues with agency personnel. Ensure timely submission approvals and product market release.


• Provide support to currently marketed products, including review of labeling, promotional material, product changes and documentation for changes.


• Support regulatory compliance activities, including facility site registrations, audits, etc., as needed.


• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.


• Provide feedback and on-going support to product development teams for regulatory issues and questions.


• Ensure personal understanding of all quality policy/system items that are personally applicable.


• Follow all work/quality procedures to ensure quality system compliance and high-quality work.


• Support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management, etc.)


• Maintain and update regulatory processes and SOPs.


• Provide support and guidance to junior team members

Other responsibilities as assigned.

Qualifications:

Must have:

• Bachelor's degree and a minimum of 4 years of regulatory experience or an advanced degree with a minimum of 2 years of regulatory experience.


• Experience with FDA Class II or III devices or experience with EU Class IIb or III devices.


• Experience working with cross-functional teams.


• Ability to comprehend principles of engineering, physiology, and medical device use.


• Ability to effectively manage and prioritize numerous projects and responsibilities.


• Strong analytical, technical writing, verbal/written communication, organizational, and time management skills.


• Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects.

Preferred:

• Experience with Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices or human tissue.

Equal Employment Opportunity Employer (EEO):
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.