Senior Regulatory Affairs Specialist

AtriCure•Minnetonka, MN

About The Position

The Senior Regulatory Affairs Specialist originates and maintains regulatory documents and marketing privileges in accordance with applicable government requirements in the markets where AtriCure conducts business. The role prepares and submits regulatory applications and notifications—including US device 510(k)s, original PMAs and PMA supplements, and submissions for the EU, Canada, Australia, Brazil, Japan, and other international markets—to support business growth and maintain marketing approvals. The specialist represents Regulatory Affairs on selected new-product development and line-extension projects, supports Design Control, risk management, and clinical evaluation activities, and provides regulatory oversight for post-market product changes. The role coordinates submissions with minimal review and sign-off responsibility, works with agency stakeholders and regional regulatory personnel, supports inspections and audits, monitors regulatory developments, and reviews technical documentation across multiple disciplines. The position requires managing multiple projects and day-to-day responsibilities while communicating progress to stakeholders.

Requirements

Bachelor’s degree or a demonstrated equivalent combination of education, training, and experience.
At least 4 years of regulatory affairs work experience, primarily with medical devices.
Knowledge of US and/or European or international regulations and standards.
Experience preparing regulatory submissions.
Experience interacting with the FDA and/or other regulatory agencies; provide examples of past agency approvals or clearances.
Strong technical writing skills.
Ability to work well in team environments and communicate effectively in a team setting.
Proficiency with Microsoft Office programs.
Demonstrated analytical abilities, a solid understanding of manufacturing and change control, and awareness of regulatory trends.
Ability to travel 10–15%.
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 containing embedded software and knowledge of electrical device standards, including Electrical Safety (IEC 60601-1) and EMC.

Responsibilities

Prepare written regulatory strategies for new product development and sustaining projects.
Prepare US regulatory submissions as needed, including 510(k) applications, original PMAs, PMA supplements for devices and manufacturing, and 510(k) letters to file.
Prepare submissions or change notifications for the EU, Canada, Australia, Brazil, Japan, and other international markets.
Represent Regulatory Affairs as a core team member on new product development projects, supporting innovation and 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.
Serve as the regulatory liaison with the FDA, EU Notified Body, Health Canada, and other government agencies to facilitate review of submissions 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 by the FDA, notified bodies, and other regulatory agencies.
Monitor changes in the regulatory environment and provide management with an assessment of their impact.
Review and provide input on technical documentation, including test reports concerning sterilization, biocompatibility, and electrical safety.
Plan, coordinate, and compile submissions with minimal review and sign-off responsibility.
Maintain current knowledge of laws, regulations, guidelines, standards, and guidance documents related to commercialization and post-market surveillance, and apply them to change-control sign-offs.
Independently manage multiple projects, department initiatives, and day-to-day tasks.
Maintain a strong working knowledge of clinical and technical concepts and applications related to commercialized products.
Perform regular and predictable work, work effectively under fast-paced conditions, exercise good judgment, prioritize and multitask, collaborate with others, and undertake additional duties as assigned.
Coordinate projects, track milestones, and communicate progress to stakeholders.
Travel 10–15% of the time.
Regularly walk, sit, or stand as needed and occasionally bend and push or pull as needed.