Senior Global Regulatory Affairs Specialist – Med Devices

AtriCure, Inc.; Mason (OH); On-site; USD 106,000 - 130,000; Full time

Job summary

AtriCure, Inc. is seeking a Senior Regulatory Affairs Specialist to prepare and submit regulatory documentation worldwide, including US 510(k) and PMA supplements, and to support EU, Canada, Australia, Brazil, Japan, and other markets.

You will serve as regulatory lead on new product development and post-market changes, collaborate with FDA and other authorities, and ensure quality documentation across sterilization, biocompatibility, electrical safety.

Qualifications

• Bachelor's degree required or demonstrated equivalent combination of education, training and experience
• A minimum of 4 years of regulatory affairs working experience, mainly for medical devices.
• Must have knowledge of U.S. and/or European/International regulations and standards
• Experience in preparing regulatory submissions; Experience interacting with FDA and/or other regulatory agencies
• Provide examples of past approvals/clearances with regulatory agencies.
• Must demonstrate good technical writing skill; Must work well in team environments; Must demonstrate good communication skill in team setting
• Proficient on programs within Microsoft Office; Proven analytical abilities, Solid understanding of manufacturing and change control, and an awareness of regulatory trends
• Ability to travel 10-15%

Responsibilities

• Prepare written regulatory strategies for new product development and sustaining projects
• Prepare US submissions including 510(k) regulatory applications, PMA supplements for device and manufacturing, drafting 510(k) letters to file to secure/maintain marketing approvals
• Prepare EU, Canada, Australia, Brazilian, Japanese, and other international submissions or notifications of change when necessary
• Represent Regulatory Affairs as core team member of new product development projects to drive innovation and to support Design Control process
• Provide Regulatory support for risk management activities and clinical evaluation
• Develop Regulatory Strategies for new or modified products and assist on project planning
• Act as the Regulatory liaison with key agency stakeholders including FDA, EU Notified Body, Health Canada, and other government agencies on behalf of the organization to facilitate timely and favorable review of submissions and pre-submission activity
• Collaborate with regional regulatory personnel on assessing and documenting the global impact of product change on product registration and license globally
• Assist in development/maintenance of regulatory operational practices
• Supports inspections and audits by FDA, notified body, and other regulatory agencies
• Monitor and provide management with impact of changes in the Regulatory environment
• Conducts reviews and provides input to the development of technical documentation including test reports across multiple disciplines including sterilization, biocompatibility, and electrical safety.
• Plans coordinate and compile submissions with minimal review and with sign-off responsibility
• Demonstrate strong working knowledge of global laws, regulations, guidelines, and standards related to commercialization and post market surveillance
• Maintain current knowledge base on existing and emerging regulations, standards, and guidance documents and apply them to change control sign-offs
• Independently manage multiple projects, department initiatives, and day-to-day tasks
• Demonstrate strong working knowledge of clinical technical concepts and applications related to commercialized products

Skills

Regulatory affairs

FDA interactions

Technical writing

Microsoft Office

Team collaboration

Travel willingness

Education

Bachelor's degree required

Job description

AtriCure, Inc. is seeking a Senior Regulatory Affairs Specialist to prepare and submit regulatory documentation worldwide, including US 510(k) and PMA supplements, and to support EU, Canada, Australia, Brazil, Japan, and other markets.

You will serve as regulatory lead on new product development and post-market changes, collaborate with FDA and other authorities, and ensure quality documentation across sterilization, biocompatibility, electrical safety.