EBR Systems, Inc.

Principal Regulatory Affairs Specialist

EBR Systems, Inc.

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $150,000 - $180,000 per year

Job Level

Lead

About the role

  • Represents the Regulatory Affairs function in project teams and leads regulatory projects in accordance with established timelines to meet corporate objectives.
  • Develops and executes sound regulatory strategies to support business goals.
  • Oversees and ensures compliance with state, federal, and international medical device regulations and overall regulatory departmental objectives for new and existing products.
  • Assists with the training and mentoring of other Regulatory Affairs team members.
  • Represents RA department in assigned project meetings and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate.
  • Evaluates possible pathways to marketing authorization and recommends pathway that appropriately weighs the probability of success with potential risks to the business.
  • Develops and executes sound regulatory strategies to support business goals with minimal oversight.
  • Assesses product and manufacturing changes and develops well-justified regulatory assessments for each global market.
  • Reviews and approves document change orders, advertising and promotional material, manufacturing nonconformances, technical documents, test protocols and reports, risk management documents, and labeling documents.
  • Directly interacts with regulatory bodies in the US and/or international regions to ensure projects remain on track and issues are resolved.
  • Develops, prepares, and submits high quality technical documentation/submissions for regulatory approval in the US and other international regions.
  • Establishes timelines, manages sub-team meetings relevant to regulatory processes, and ensures timely execution.
  • Prepares reports for management and develops metrics and proposals for regulatory process improvements.

Requirements

  • Bachelor's degree in a scientific, engineering, or technical discipline is required.
  • Minimum 7 years of directly relevant Regulatory Affairs experience within the medical device or other regulated industry.
  • An advanced degree may supplement some professional experience.
  • Experience with Class III active implantable medical devices is preferred.
  • Strong knowledge of US and international medical device regulations.
  • Ability to interpret regulatory requirements and provide actionable guidance to cross-functional team members.
  • Demonstrated experience with successful submissions and strategic planning.
  • Ability to work in collaborative and independent work situations and environments with minimal supervision.
  • Willingness and able to travel approximately 10% of the time.
Benefits
  • Medical, dental, and vision insurance provided at no cost for employee-only coverage
  • 401(k) matching plan
  • Paid Time Off – starting at 3 weeks per year
  • Competitive salary with opportunities for career growth
  • Employee stock options
  • Life & AD&D and long term disability insurance
  • Education assistance
  • Voluntary commuter benefits and pet insurance
  • Weekly company lunches and occasional happy hour events
  • Meaningful work and much more!
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategiesregulatory compliancetechnical documentationmarketing authorizationregulatory assessmentssubmissionsrisk managementdocument change ordersadvertising material reviewmanufacturing nonconformances
Soft Skills
leadershipmentoringcollaborationindependent workcommunicationproblem-solvingstrategic planningtime managementreport preparationguidance provision