Principal Regulatory Affairs Specialist

Braccomedtech; Minnesota; On-site; USD 100,000 - 130,000; Full time

Job summary

A medical device company located in Minnesota is seeking a Principal Regulatory Affairs Specialist to develop and implement regulatory strategies for products and processes. The role requires at least 7 years of experience in medical device regulatory affairs, with responsibilities that include managing 510(k) submissions and communicating with regulatory agencies. The ideal candidate will demonstrate effective skills in project management and problem-solving while ensuring compliance with relevant regulations.

Qualifications

• 7+ years of experience in medical device Regulatory Affairs.
• Experience with 510(k), EU CE Marking, and Health Canada submissions.
• Strong written and verbal communication skills.
• Ability to develop clear reports and communicate complex information.

Responsibilities

• Develop and execute regulatory plans for product submissions.
• Coordinate support for global registrations.
• Communicate with regulatory agencies and lead meetings.
• Maintain all regulatory files and documentation.

Skills

Regulatory Affairs expertise

Communication skills

Critical thinking

Project management

Education

Bachelor’s degree

Job description

Principal Regulatory Affairs Specialist

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.

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, assess potential impact(s), and recommend alternatives to ensure compliance with all standards and regulations.
• 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 oversight of junior regulatory staff and provide training and guidance for cross‑functional partners.

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.

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.

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.