Regulatory Affairs Specialist II

Katalyst CRO; Seattle (WA); On-site; USD 95,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking an experienced Regulatory Affairs professional to drive submissions for U.S. and European medical devices. You will guide product development with regulatory input, coordinate inputs across R&D, Quality, Medical, and Manufacturing, and ensure compliance with 21 CFR 820 and ISO 13485.

The ideal candidate holds a B.S. in life sciences or engineering, 2–5 years of device regulatory experience, RAC certification, knowledge of 510(k) and EU MDR/MDD, plus strong communication

Qualifications

• B.S. degree or higher in life science or technical discipline.
• 2-5 years Medical Device experience.
• Working knowledge of industry consensus standards and FDA guidance.
• Regulatory Affairs experience in Medical Device regulations (FDA/EU).
• RAC (RAPS) certification.
• Strong communication and project management skills.
• Proficient in Microsoft Office.
• Ability to manage multiple tasks and attention to detail.

Responsibilities

• Prepare regulatory submissions for U.S. and Europe to market medical devices.
• Represent RA on project teams and review design control docs.
• Support International Product Registrations and changes.
• Coordinate registration information with R&D, Quality, Medical, Manufacturing.
• Assess need for 510(k) and prepare non-filing justifications.
• Prepare/update technical files for CE marking with input from functions.
• Submit notifications to EU Notified Body for CE changes.
• Maintain regulatory documentation and support special projects.

Skills

Regulatory Affairs

FDA guidance

510(k) knowledge

EU CE marking

RAC certification

Project management

MS Office

Communication skills

Multitasking

Attention to detail

Education

Life science/Engineering degree

Job description

Responsibilities

• This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail.
• Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation.
• Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications.
• Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc.
• Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications (U.S.) for changes that do not require a 510(k) submission.
• Prepare/update technical files for CE marking with appropriate input from various functions (R&D, Quality, Medical, Manufacturing, etc.).
• Submit notifications to the EU Notified Body for significant changes to CE marked products.
• Maintain Regulatory documentation.
• Support special projects, as needed.

Requirements

• B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry
• 2-5 years Medical Device experience
• Working knowledge of industry consensus standards and FDA guidance is required
• At least 2 years Regulatory Affairs experience in Medical Device regulations
• Demonstrated success in taking products through FDA and EU Notified Bodies
• Working knowledge of 510(k), MDD 93/42/EEC
• Regulatory Affairs Certified RAC (RAPS)
• Proficient in using Microsoft Office
• Strong communication and project management skills
• Must be able to handle multiple tasks
• Attention to detail
• 510(k), MDR
• 21 CFR 820 - Quality System Regulation, ISO 13485
• Medical device standards and FDA guidance relevant to medical devices.