The Regulatory Affairs Specialist is responsible for preparing international regulatory filings and registrations especially for ISD (International Sales Domain), which is mainly managed by reseller companies rather than Canon Medical subsidiaries through significant work with cross-functional teams. The Regulatory Affairs Specialist will ensure compliance with ISD and international regulations, standards and guidance and will assist with post-market review of product issues and other projects in international arenas.
RESPONSIBILITIES
- Prepare ISD and international submissions for new products and product changes as required to ensure timely approval for market release and in accordance with applicable regulations, standards, and guidance.
- Provide guidance to work teams comprised of senior engineering and marketing personnel regarding regulatory planning and execution.
- Review and analyze product complaints for appropriate international filings as part of product post-market surveillance.
- Advise technical, marketing and sales personnel on regulatory requirements (e.g., Design Controls, CE Marking, Labeling, Promotion).
- Provide guidance and review of product labeling, promotional material, change control and other related product documentation.
- Maintain database(s) for the worldwide regulatory status of products.
- Maintain regulatory affairs product files to support compliance with requirements and standards.
- Assist with regulatory audits from partners and external regulatory agencies
- Generate technical files and declarations of conformance required for ISD submissions.
- Maintain the company's Medical Device Listing and Device Establishment registration forms.
- Interpret, execute, and recommend modification to internal guidelines, work instructions, procedures.
- Monitor industry and regulatory trends and develop strategy and provide guidance related to such trends
REQUIRED EDUCATION AND SKILLS
- Bachelor's Degree in Engineering, Life Sciences or Regulatory Affairs or related field.
- 2+ years of experience in domestic/international regulatory submissions, design control systems and/or regulatory compliance.
- Experience with product registration requirements of various international countries including European MDD/MDR (Class IIa).
- Experience with registrations in Asia, Middle East, Africa, Australia, South America, Japan, Turkey and EMEA preferred.
- Experience with ISO 13485, EN 62366, ISO 14971, FDA QSR, and IEC 62304 preferred.
- Ability to communicate complex ideas clearly and simply, orally and in writing.
- Ability to raise issues with colleagues and managers in a proactive, professional manner Ability to build relationships across functional boundaries at multiple levels.
- Strong technical, analytical and problem-solving skills 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.
- 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.
- 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.
- Research/Information Finding - Finds needed data through known sources; has good contacts or source knowledge; uses resourcefulness to tap as-yet-unknown sources; identifies, sorts, and categorizes source materials to deliver most pertinent information.
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.
Vital Images is an Equal Opportunity Employer, M/F/Vets/Disability.