Principal Regulatory Affairs Specialist

Why Join Bracco Medical Technologies?

At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesaving decisions. We create medical devices that give healthcare providers the insights they need to confidently and safely diagnose patients. Our unique line of products includes Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR), Cardiovascular Imaging contrast delivery (CVi), and CT and MRI contrast delivery systems.

Position Description

Position Summary:

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 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.

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, provide strategic regulatory direction and communicate global regulatory requirements and strategy to project teams and cross-functional partners.

• Review, edit and approve project documentation as the active regulatory representative on project teams.

• 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.

• Maintain all regulatory files ensuring documentation and registrations are complete and up to date.

• Mentor, develop, and provide oversight of junior regulatory staff and provide training and guidance for cross-functional partners.

• 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.

Qualifications (Knowledge, Skills & Abilities):

Minimum

• Bachelor’s degree

• Minimum of 7+ years of experience in Regulatory Affairs

• Minimum of 6 years medical device industry experience including strong 510(k) submission experience, 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

• Effective written and verbal communication skills, technical writing and editing skills necessary for high-quality regulatory submission documents

• Proven track record of successfully leading FDA meetings, such as pre-submissions and submission issue request meetings

• Ability to develop clear, concise, and timely oral and written reports

• Ability to communicate complex information and regulatory decisions tactfully to all levels of personnel

• Ability to explain technical materials concisely to audiences of varying degrees of familiarity

• Ability to solve complex problems through the application of critical thinking skills

• Effective research and analytical skills

• 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

• 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

• Works effectively in a matrixed environment and influences internal partners to achieve desired business outcomes

• Serves as role model and embraces corporate values and behaviors

• Meets individual goals as defined in the annual objectives.

• Ability to assess and recommend alternatives to ensure compliance with standards and regulations

• Knowledge of medical terminology

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

• Strong FDA, Health Canada, TGA, and EU submission experience, including EU MDR

• International regulatory submission experience, including Japan and China

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:

Estimated Starting Salary Range: $135,000.00 – $160,000.00

*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.

Total Rewards:

Paid Time Off, Company Holidays & Paid Family Leave – We provide PTO and Company Holidays to help you recharge, relax and do what’s important to you, when it’s important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
Achieve – Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
Live well – We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
Evolve – Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you’ll find many opportunities to grow, personally and professionally.
Choose – You won’t find “stuffy” here—whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.

Bracco Medical Technologies is an Affirmative Action/Equal Opportunity Employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings.

Job Location

7905 Fuller Road, Eden Prairie, Minnesota

Tracking Code

1393-432

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