Position Summary:

The Principal Regulatory Affairs Specialist is responsible for the development and implementation of the regulatory strategy (as applied to project, process, and/or product) and partners with internal stakeholders (e.g., regions) to align on an optimized regulatory strategy in order to achieve business objectives. This individual will provide hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements/strategies and preparation of submissions, perform regulatory submission/approval activities for specific complex ACIST Medical Systems products, represent ACIST Regulatory with US and international regulators on submission reviews/approvals and ensure compliance with required regulations and established corporate standards, ensure that product approvals are properly maintained and product re-registrations are properly managed. This individual will exercise creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks.

Primary Duties & Responsibilities:

• Develop and prepare regulatory plans and author 510(k) Premarket Notifications, EU MDR Technical Documentation, Canadian Licensing Submissions, and contribute content to Japan submissions. Also, coordination of staff support for worldwide registrations for global product growth and market expansion.
• Participate as regulatory representative on project teams throughout the project lifecycle, provide strategic product 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.
• Communication with government regulatory agencies and Notified Bodies and Prepare and conduct meetings / teleconferences with external regulatory agencies as assigned.
• Maintain all regulatory files ensuring documentation, registrations, directories and lists are complete and up to date.
• Mentorship and development of junior regulatory staff and training for cross-functional partners.
• Review of device labeling in all forms and advertising materials for compliance with FDA submissions and applicable regulations; analyze and recommend appropriate changes.

Minimum

• Where permitted by applicable law, must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for U.S.-based job, if not currently employed by ACIST Medical Systems
• BA degree.
• Minimum of 7 years of experience in Regulatory Affairs or similar field.
• Minimum of 6 years medical device industry experience including strong 510(k) submission experience, EU CE Mark submissions, and Health Canada submissions.
• Understanding of FDA, EU, Australia and Canada regulatory framework including how to comply with standards and regulations.
• Strong knowledge of quality system requirements, regulations, and guidelines including design controls, risk management, and product development processes.
• Strong writing skills in the form of high-quality regulatory submission documents.
• Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel.
• Experience establishing and managing plans and timelines to achieve desired outcomes.
• Ability to solve problems through the application of critical thinking skills.
• Effective written and verbal communication skills, technical writing and editing skills.
• Ability to convey technical materials concisely to audiences of varying degrees of familiarity.
• 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.
• 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.
• Travel requirements are minimal. Travel about 2-3 times annually for 2-3 days duration each trip.

Preferred:

• RAC Certification.
• Bachelor’s degree in Science, Engineering or related technical discipline.
• 8 years or greater of experience in medical device industry.
• 8 plus years working in Regulatory Affairs.
• Strong FDA, Health Canada, TGA, and EU submission experience, including EU MDR.
• International submission experience, including Japan and China.

Other:

• Requires intense concentration in order to accurately assess compliance to applicable regulations for medical device manufacturers and comparing them to processes, policies, procedures and other quality related documentation, which may involve point-by-point comparisons.
• The work is detail oriented, often with multiple priorities
• The environment is deadline sensitive, with frequent high-pressure situations.