Principal Regulatory Affairs Strategist

POSITION OVERVIEW

We are looking for a talented Principal Regulatory Affairs Strategist to join our team at Canon Medical Informatics In this role, you will orchestrate U.S. pre-market activities including product planning and remedial actions on released products, as well as spearheading efforts to generate and submit 510k submissions. Additionally, you will have a chance to use your regulatory expertise to develop and implement long-range regulatory strategies for medical software product clearance in the U.S.

RESPONSIBILITIES

Responsible for streamlining our regulatory QMS documentation strategy to ensure we are complying the U.S. requirements.
Works with Product Management to define/plan which applications or changes would require new FDA submissions.
Prepare FDA submissions for new HIT products and HIT product changes to ensure timely approval for market release in accordance with all applicable regulations, standards, and guidance.
Lead and provide guidance on regulatory planning and execution to work teams comprised of Senior Engineering and Product Management personnel.
Organizing pre-sub meetings with FDA. Generate and submit HIT 510k submissions.
Review, advise and provide guidance to technical, marketing and sales personnel on Marketing and Sales promotion materials.
Provide a leadership role during discussion with FDA on product submissions and pre-submission meetings.
Assist with regulatory audits from partners and U.S. external regulatory agencies.
Support legal/regulatory actions as required by the legal department or directed by the Senior Director, Regulatory Affairs.
Interpret, execute, and recommend modification to internal guidelines, work instructions, procedures based on changes to U.S. regulations.
Monitor industry and regulatory trends and develop strategy and provide guidance related to such trends.
Performing analysis of competitor’s regulatory filings.
Strategizing regulatory paths during the early concept phase based on alternate market requirements & value propositions.
Providing guidance on clinical validation requirements.
Participates in FDA meetings related to software, artificial intelligence (ML/DL) and coordinates company comments and responses as deemed necessary by management.
Provide input to CMI Regulatory group (EU) to assure that there is consistency in meeting regulatory requirements.

REQUIRED EDUCATION AND SKILLS

5+ years direct FDA experience working on standalone clinical software submissions (i.e. PACS, Advanced Visualization and clinical applications)
Bachelor's Degree in Regulatory Affairs or Engineering Sciences. Graduate Degree in Regulatory Affairs or Software Engineering preferred
Current knowledge of all U.S. laws pertaining to software as a medical device FDA product (Class ll) submission
Strong experience with FDA QSR, ISO 13485, IEC 62304 for software lifecycle management, ISO 14971 and EN 62366
Experience with software automation, Artificial Intelligence, CAD(e), CAD(x), and CAD(t) type submissions
Strong interpersonal and leadership skills, including influencing skills and ability to lead in a collaborative, cross-functional environment.
Strong technical, analytical, and proactive problem-solving skills, including strong critical thinking and project management skills.

JOB COMPETENCIES

Adaptability/Flexibility - Adapts to change, is open to new ideas, takes on new responsibilities, handles pressure, adjusts plans to meet changing needs.
Quality Work – Is attentive to detail and accuracy, is committed to excellence, looks for improvements continuously, monitors quality levels, finds root cause of quality problems, owns/acts on quality problems.
Global Perspective - Has a global view and is comfortable and effective working with global partners, understands global markets and international considerations.
Listening Skills - Listens attentively to others, asks clarifying questions, actively listens, stays open to other viewpoints, manages distractions and interruptions.
Information Gathering - Maintains and informs other departments in changes and trends regarding U.S. FDA regulations, guidance documents, clinical requirements, etc.

COMPANY OVERVIEW

At Canon Medical Informatics (formerly Vital Images, Inc.), what we do matters. This is at the heart of every product we develop, every service we provide, and especially each member of our team. As part of Canon Medical Systems Corporation, we lead the industry with the latest health imaging informatics solutions. We improve the quality of patient care by developing innovative products that enable the exchange, analysis and storage of clinical information across health care enterprises and communities. Our products handle millions of medical images and health records a day across the world. Canon Medical Informatics experiences the best of both worlds with a dynamic and collaborative environment, casual culture, and agility of a mid-sized company, while having the support and resources of Canon Medical Systems Corporate, our parent company.

Our offices are based in Minnetonka, Minnesota; Waterloo, Ontario; Copenhagen, Denmark; The Netherlands; and Beijing, China. We value our team’s innovation, enthusiasm, and dedication to help improve the lives of patients. Do you want to be part of a passionate team that believes what we do matters? Then a career with Canon Medical Informatics might be right for you

COMPANY VALUES

Unity, Courage, Tenacity, Teamwork, and Excellence

WHAT WE OFFER YOU

Canon Medical Informatics offers a dynamic workplace, competitive compensation package, and room for learning and growth in our organization. This is an environment in which things move quickly and you’ll have the opportunity to wear many hats. We have a casual dress code, offer flexible work hours and actively foster work-life balance, because anything else simply isn’t sustainable. Our Minnetonka, MN office is located about 12 miles southwest of downtown Minneapolis. Our office is near several walking paths and restaurants that are a quick drive away. In our office of 175, we have on onsite deli, workout facility and weekly massages. Our team loves what we do and has fun doing it together. We look forward to receiving an application from you.

Canon Medical Informatics is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, color, religion, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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