Senior Regulatory Affairs Specialist

AtriCure • Mason, OH

8h • $106,000 - $129,000

About The Position

The Senior Regulatory Affairs Specialist prepares and maintains regulatory documentation and marketing approvals in accordance with applicable government requirements in the regions where AtriCure operates. The role prepares regulatory submissions—including US 510(k) applications, original PMAs and PMA supplements, and submissions for the EU, Canada, Australia, Brazil, Japan, and other international markets—to support business growth and maintain product approvals.

The specialist represents Regulatory Affairs on selected new-product development and product-line-extension projects, supports design control, risk management, and clinical evaluation, and provides regulatory oversight for post-market product changes. The position also works with agencies and regional regulatory personnel, supports audits and inspections, monitors regulatory changes, and independently manages multiple projects and daily responsibilities.

Requirements

• Bachelor’s degree or demonstrated equivalent combination of education, training, and experience.
• At least 4 years of regulatory affairs work experience, primarily involving medical devices.
• Knowledge of US and/or European or international regulations and standards.
• Experience preparing regulatory submissions and interacting with FDA and/or other regulatory agencies.
• Provide examples of past regulatory agency approvals or clearances.
• Strong technical writing, communication, and teamwork skills.
• Proficiency with Microsoft Office programs.
• Proven analytical abilities, a solid understanding of manufacturing and change control, and awareness of regulatory trends.
• Ability to travel 10–15%.
• Regular and predictable work performance; ability to work in fast-paced conditions, exercise good judgment, prioritize and multitask, and work successfully with others.
• Ability to regularly walk, sit, or stand as needed and occasionally bend and push or pull as needed.
• Ability to pass a pre-employment drug screen and background check.

Nice To Haves

• Four-year degree in a technical or scientific discipline.
• Work experience with cardiac devices, including capital equipment.
• Experience with medical capital equipment with embedded software and knowledge of electrical device standards, including IEC 60601-1 electrical safety and EMC.

Responsibilities

• Prepare written regulatory strategies for new-product development and sustaining projects.
• Prepare US regulatory submissions, including 510(k) applications, original PMAs, PMA supplements for devices and manufacturing, and 510(k) letters to file.
• Prepare EU, Canadian, Australian, Brazilian, Japanese, and other international submissions or change notifications as needed.
• Represent Regulatory Affairs as a core team member on new-product development projects and support the Design Control process.
• Provide regulatory support for risk management activities and clinical evaluation.
• Develop regulatory strategies for new or modified products and assist with project planning.
• Act as regulatory liaison with FDA, EU Notified Bodies, Health Canada, and other government agencies to facilitate submission reviews and pre-submission activity.
• Collaborate with regional regulatory personnel to assess and document the global impact of product changes on registrations and licenses.
• Assist in developing and maintaining regulatory operational practices.
• Support inspections and audits conducted by FDA, notified bodies, and other regulatory agencies.
• Monitor changes in the regulatory environment and communicate their impact to management.
• Review and provide input on technical documentation, including test reports covering sterilization, biocompatibility, and electrical safety.
• Plan, coordinate, and compile submissions with minimal review and sign-off responsibility.
• Maintain and apply knowledge of global laws, regulations, guidelines, and standards related to commercialization and post-market surveillance.
• Maintain current knowledge of 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 working knowledge of clinical technical concepts and applications related to commercialized products.
• Coordinate projects, track milestones, and communicate progress to stakeholders.
• Perform additional duties as assigned.

Benefits

• Medical insurance beginning on the first day of employment.
• Dental insurance beginning on the first day of employment.
• 401(k) with employer match.
• 30 days of paid parental leave, in addition to maternity leave.
• Volunteer time off.
• Pet insurance.
• Corporate-based employees have access to an on-site fitness center and cafeteria.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior