Principal Regulatory Affairs Specialist

Acist Medical Systems Inc.; Eden Prairie (MN); Presencial; USD 132.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Paid time off

Company holidays

Paid family leave

Retirement savings

Tuition reimbursement

Professional development opportunities

Descripción de la vacante

Bracco Medical Technologies is seeking a Principal Regulatory Affairs Specialist to develop and implement regulatory strategies across projects and products, partnering with internal and external stakeholders to optimize submissions and maintain approvals. The role covers 510(k), EU MDR, and Health Canada submissions, global registrations, and regulatory leadership across the product lifecycle.

Expect minimal travel and a focus on crossing regulatory milestones with digital tooling.

Formación

• Minimum Bachelor’s degree plus 7+ years of experience in medical device Regulatory Affairs.
• Demonstrated experience with 510(k), EU CE Marking, and Health Canada submissions.
• Understanding of FDA, EU MDD and MDR, Australia and Canada regulatory framework.
• Experience leading FDA meetings, such as pre-submissions and submission issue requests.
• Effective written and verbal communication skills, technical writing and editing skills.
• Ability to develop clear, concise, and timely oral and written reports for diverse audiences.
• Proficiency with digital productivity and generative AI tools to support document development, data analysis, and process efficiency.

Responsabilidades

• Develop and execute regulatory plans including 510(k) and EU MDR submissions.
• Coordinate cross-functional support for worldwide registrations for global product growth.
• Represent regulatory on project teams throughout the product lifecycle.
• Lead meetings with government authorities (FDA) and support audits.
• Mentor junior staff and provide regulatory guidance to partners.
• Leverage AI tools to improve efficiency and ensure compliance.

Conocimientos

Regulatory strategy

FDA meetings experience

Cross-functional collaboration

Technical writing

AI tools usage

Educación

Bachelor’s degree in science/engineering

RAC Certification

Herramientas

Microsoft 365 Copilot

Descripción del empleo

Why Join Bracco Medical Technologies?

We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day!

The Principal Regulatory Affairs Specialist is responsible for developing and implementing regulatory strategies across projects, processes, and/or products. This individual partners with internal stakeholders and external consultants to optimize and execute these strategies in support of business objectives. This role provides hands‑on regulatory affairs support for new product marketing submissions and changes to existing devices, including development of regulatory requirements/strategies and preparing submissions. In addition, this individual will represent BMT Regulatory in interactions with US and international regulators during submission reviews/approvals and audits. This individual will ensure compliance with required regulations and established corporate standards and ensure that product approvals are properly maintained. This position requires creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks to drive successful outcomes. This individual serves as a regulatory subject matter expert and strategic partner, leveraging regulatory expertise, digital technologies, and AI tools to support efficient, high‑quality regulatory outcomes.

Primary Duties & Responsibilities

• Develop and execute regulatory plans and author 510(k) Premarket Notifications, EU MDR Technical Documentation, Canadian Licensing Submissions, and contribute content to Japan and China submissions.
• Coordinate cross-functional support for worldwide registrations for global product growth and market expansion.
• Participate as regulatory representative on project teams throughout the product lifecycle.
• Review, Edit and approve project documentation, provide strategic regulatory direction and communicate global regulatory requirements and strategy to project teams and cross-functional partners.
• Communicate with government regulatory agencies and Notified Bodies; prepare for and lead meetings / teleconferences with external regulatory authorities, including the FDA, and support audits and inspections as assigned.
• Identify new and emerging regulations, guidance documents, standards, and industry trends; assess potential business and regulatory impact, communicate changes to stakeholders; recommend strategies to ensure compliance and support business objectives.
• Contribute content for and review all forms of device labeling and advertising materials for compliance with FDA submissions and applicable global regulations; analyze and recommend appropriate changes.
• Serve as the primary point of contact with external regulatory consultants, when applicable, coordinating their contributions and ensuring alignment with internal regulatory strategies and timelines.
• Maintain all regulatory files ensuring documentation and registrations are complete and up to date.
• Demonstrates strong planning, organizational and time management skills, including the ability to work on multiple projects and adhere to timelines to achieve desired outcomes.
• Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.
• Commits to driving efficiency while maintaining quality, and ensures timely, clear communications to internal stakeholders on project status and issues.
• Supports the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks.
• Mentor, develop, and provide technical leadership to junior regulatory staff; promote best practices; provide training and regulatory guidance to cross-functional partners.
• Leverage digital, automation, and generative AI tools to improve the efficiency, quality, consistency, and predictability of regulatory deliverables while ensuring compliance with company policies, confidentiality requirements, and applicable regulations.
• Drive continuous improvement initiatives that enhance regulatory processes, document quality, submission readiness, inspection preparedness, and operational efficiency.
• Travel requirements are minimal. Travel up to 1-2 times annually for 2-3 days duration each trip.

Qualifications (Knowledge, Skills & Abilities)

• Minimum Bachelor’s degree plus 7+ years of experience in medical device Regulatory Affairs
• Demonstrated experience with 510(k), EU CE Marking, and Health Canada submissions
• Understanding of FDA, EU MDD and MDR, Australia and Canada regulatory framework including how to comply with standards and regulations
• Experience successfully leading FDA meetings, such as pre-submissions and submission issue request meetings
• Effective written and verbal communication skills, technical writing and editing skills.
• Ability to develop clear, concise, and timely oral and written reports, and communicate complex information and regulatory decisions tactfully and concisely to all levels of audiences with varying degrees of familiarity
• Ability to solve complex problems through the application of critical thinking skills
• Demonstrated proficiency using approved digital productivity and generative AI tools (e.g., Microsoft 365 Copilot or equivalent) to support document development, data analysis, research, communication, and process efficiency while maintaining appropriate human oversight and accountability for final work product.

Preferred

• RAC Certification
• Bachelor’s degree in science, engineering or related technical discipline
• 10+ years or greater of experience in the medical device industry
• 10+ years or greater working in Regulatory Affairs
• Advanced level of FDA, Health Canada, TGA, and EU submission experience, including EU MDR
• International regulatory submission experience, including Japan and China
• Ability to work effectively in a matrixed environment and influence internal partners to achieve desired business outcomes
• Experience evaluating regulatory considerations associated with software-enabled, connected, cybersecurity-focused, artificial intelligence (AI), and machine learning-enabled medical devices.

Other

• Requires high concentration and attention to detail to accurately assess compliance to applicable regulations for medical device manufacturers and comparing them to internal processes, policies, procedures and other quality-related documentation, which may involve point‑by‑point comparisons
• The work is detail oriented, often with multiple or competing priorities
• The environment is deadline sensitive, with frequent high‑pressure situations
• Travel requirements are minimal.
• Travel up to 1-2 times annually for 2-3 days duration each trip

Compensation & Total Rewards

The estimated base salary range for this position is $132,000–$160,000 annually. Actual compensation may vary based on relevant experience, skills, education, internal equity, and business needs.

• Health benefits
• Paid time off
• Company holidays
• Paid family leave
• Retirement savings
• Tuition reimbursement
• Professional development opportunities

Bracco Medical Technologies is an Equal Opportunity Employer.

Employment decisions are made without regard to race, color, religion, sex, national origin, disability, protected veteran status, age, or any other characteristic protected by applicable law.

Improve people’s lives by shaping the future of prevention and precision imaging. This is our purpose. Our work impacts millions of people all over the world. Not least the more than 4,000 Bracco colleagues who work to improve lives every single day. That is quite a responsibility and something we proudly embrace. We are the Bracco Group!