Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where Atri Cure conducts business. This position will prepare and submit submissions, which may include US device 510(k), PMA Supplements or original PMAs, EU, Canada, Australia, Brazilian, Japanese, and other international submissions to support business growth. The position will serve as regulatory representative on selected projects for new product development or line extension and will provide regulatory supervision on post-market product changes to maintain marketing approvals.

• Prepare written regulatory strategies for new product development and sustaining projects
• Prepare US submissions as necessary including 510(k) regulatory applications, original PMAs & 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

• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgement
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned
• Ability to coordinate projects, track milestones and communicate progress to stakeholder

• 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%

• 4-year degree in a technical/scientific discipline
• Working experience with cardiac devices, including capital equipment
• Experience with medical capital equipment with embedded software and knowledge of electrical device standards, ie. Electrical Safety (IEC 60601-1) and EMC

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and…