About the Job

As the Regulatory Affairs Specialist, you will support Fluke Biomedical’s portfolio for US and OUS Global product launches. You will assess intelligence to develop local to global regulatory strategies, completing submissions pertaining to product clearances and approvals by FDA, Notified Bodies, and other regulatory bodies. You will collaborate closely with internal customers and... external regulatory authorities to maintain regulatory compliance of Fluke Biomedical products globally.

Responsibilities
• Possess and apply knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to maintain compliance of a large portfolio of medical device testing equipment
• Define requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
• Author FDA submissions, and other regulatory documents to obtain approval of device design changes
• Review and approve engineering change orders as part of ongoing regulatory assessments to evaluate whether new 510(k) submissions are required
• Review and interpret new regulatory requirements and develop implementation plans
• Train Fluke Biomedical departments on new/revised FDA guidance, regulations, or standards
• Provide regulatory affairs support for new product development and sustaining efforts in both the domestic and international markets
• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission
• Review labeling, marketing literature, and promotional materials for compliance
• Provide project support for registration and licensing in new markets
• Identify areas for improvement for efficiency and compliance in the internal processes, work instructions, and forms and apply technical expertise to lead process improvement efforts in Kaizens
• Maintain annual licenses, registrations, and listings for registered devices
• Minimum of a B.S. or B.A in an engineering or scientific subject area or equivalent required, advanced degrees, or certifications preferred
• 5+ years in the FDA regulated medical device industry within regulatory affairs
• Experience working with new product development teams for assigned products, provide regulatory analysis on the product development plan and collaborating with Business functions as needed to resolve regulatory concerns
• Proven understanding of FDA requirements, guidance documents, ISO 14971, ISO 13485, and other global requirements and quality standards
• Good understanding of the product development and design control process through knowledge of US FDA and international medical device regulations
• Experience supporting project teams for regulatory projects with Business Unit Impact, to include the management of project team personnel, development of an executable quality plan, coordination with partnering functions/departments/resources and maintaining the schedule and budget
• Experience leading special regulatory projects and process improvement projects, including developing project plans and supervising progress
• Detailed experience in the creation and execution of regulatory strategies and plans for products in the domestic, mature, and emerging markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers
• Experienced in new product licensing and registration submissions in the US
• Experience supervising pending domestic and global changes, develops and implements quality plans to minimize impact to the Business Unit

Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 17,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

Ready to move your career forward? Find out more at careers.fortive.com.

Fluke Health Solutions (FHS), an operating company of Fortive, is comprised of 3 industry leaders – LANDAUER, Fluke Biomedical, Victoreen, and RaySafe. We lead the biomedical and radiation detection markets with innovative products and services to keep customers, patients, and clients safe. Our portfolio of products includes software, biomedical test equipment, radiation measurement and radiation detection.

The Fluke Health Solutions vision is to empower our everyday heroes to focus only on protecting lives.

How We Work

Though we’re spread across operating companies, teams, and time zones, the Fortive culture is a powerful unifying force. It’s a commitment to continuous improvement and striving for better every day. It’s facing challenges head on, speaking your mind, and being yourself. It’s working together for a sustainable future. It’s celebrating wins and learning from failures as a team.

We Are an Equal Opportunity Employer

Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment process should ask to speak with a Human Resources representative to request an accommodation.

Everett, WA: The salary range for this position is $70,495- $130,985

Base pay offered may vary depending on various factors, including, but not limited to: job-related knowledge; skills; experience; and other eligibility factors such as geographic location. The Total Rewards package includes competitive base pay and an opportunity to enroll in a variety of benefit programs, generally including health insurance, flexible spending accounts, health savings accounts, retirement savings plans, life and disability insurance programs, and several programs that provide for both paid and unpaid time away from work
Everett WA USA

Salary Criteria