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Regulatory Affairs Associate

Regulatory Affairs Associate

FUJIFILMBothell, WA, US
12 days ago
Job type
  • Full-time
Job description

Regulatory Affairs Associate

The Regulatory Affairs Associate requires application of regulatory knowledge and project management skills to oversee international registration new products. As a Regulatory Affairs Associate you will also work with Regulatory team members & international teams to drive systems & process improvement activities for integrated regulatory compliance and global submission processes, including labelling, clinical affairs, new product development, international regulatory requirements and other areas as assigned.

At FUJIFILM Sonosite, we reinvent how healthcare is delivered with point-of-care ultrasound technology. As the leader in bedside ultrasound systems, our innovations save livesfrom premature babies in NICUs to trauma patients in emergency rooms.

We're looking for purpose-driven team members ready to build technology that impacts real-world scenarios, including natural disasters and even war zones. By joining FUJIFILM Sonosite, you'll be part of a team that thrives on collaboration, out-of-the-box thinking, and a passion for life-saving innovations. Let's make a difference together.

Our headquarters in Bothell, Washington, blends riverside charm with urban amenities, quality schools, and an ever-evolving downtownall part of the vibrant Seattle metro area.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles."

Job Description

Essential Job Functions :

  • Author and submit regulatory technical files for international registrations, including license renewals.
  • Work with Regulatory partners and product management to prepare regulatory schedule for Global Submissions
  • Works with international counterparts to ensure product registrations are completed in a timely manner. Support legalization requests.
  • Support R&D team with regulatory questions and requests.
  • Develop, implement and train employees in regulatory processes and procedures.
  • Maintain current, quality system regulatory standards / guidance and product approval documents in applicable database locations that affect SonoSite Quality System standards.
  • Responsible and accountable for carrying out the requirements of the company's quality system.
  • Must be able to maintain facility registrations, as needed.

Knowledge / Experience :

  • A minimum of a Bachelor's degree (advanced degree or professional certification is preferred) or a combination of work history and education.
  • A minimum of 1-2 years of direct experience in Regulatory Affairs

    • The following areas of experience are highly preferred :

  • Proven experience preparing and managing regulatory submissions
  • Strong knowledge and experience of Quality Management System processes, include design controls and development or documentation of procedures
  • Familiarity with FDA regulations and major international market such as Canada, EU, Brazil, Japan, and Australia
  • Regulatory Project Management skills are required
  • Experience working with FDA Class II electromechanical medical devices preferred

    • Skills / Abilities :

  • Excellent analytical and writing skills
  • Effective interpersonal communication skills
  • Time and project management
  • Superior competency in MS Word, Adobe Acrobat and / or other PDF toolset.
  • Ability to work independently and under pressure (able to prioritize tasks, deadline oriented, good organizational and problem-solving skills, follow-up skills).
  • Committed attention to detail : accurate and meticulous.

    • Salary and Benefits :

  • $29.81 / hr - 32.69 / hr. depending on experience (Compensation will vary based on skills, experience and location; it is not typical to be hired at or above the top of the salary range).
  • Insurance :
  • Medical, Dental & Vision
  • Life & Company paid Disability
  • Retirement Plan (401k) :
  • 4% automatic Company contribution
  • Fujifilm matches 50 cents for every dollar you contribute, up to 6% of your salary
  • Paid Time Off :
  • You can accrue up to three (3) weeks of PTO in your first year of employment
  • PTO increases based on years of service
  • Employee Choice Holidays :
  • Four (4) additional paid days off, based on date of hire in the calendar year
  • Paid Holidays :
  • Eight (8) paid holidays per year

    • EEO Information

    Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

    ADA Information

    If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (ffss-hr@fujifilm.com or (425) 951-1200).

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    Associate Regulatory • Bothell, WA, US