Talent.com
Regulatory Affairs Manager
Regulatory Affairs ManagerKatalyst HealthCares & Life Sciences • Seattle, WA
Regulatory Affairs Manager

Regulatory Affairs Manager

Katalyst HealthCares & Life Sciences • Seattle, WA
30+ days ago
Job type
  • Full-time
Job description

Responsibilities :

  • Support and advise cross-functional teams and communicate APAC regulatory requirements and challenges effectively to meet project needs and company objectives.
  • Oversee and direct the development of priorities, timelines, receipt of technical information from appropriate sources, and the preparation of regulatory documentation for new products, amendments of approved products, and submissions that support the maintenance of existing licenses.
  • Support in implementation of policies, procedures, practices, and strategies to facilitate support of in-country product registrations in APAC.
  • Work closely with regional APAC regulatory team to develop and drive process efficiencies for APAC regulatory submissions.
  • Review and evaluate issues that may create regulatory or business obstacles and propose solutions.
  • Monitor APAC regulations / guidelines and the impact of changing / evolving regulations on submissions, practices, and procedures, and communicate to appropriate stakeholders.
  • Manage the performance and career development of direct reports.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
  • While performing the duties of this job, the employee is regularly required to talk or hear.
  • The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms.
  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requirements :

  • Bachelor's degree required, years direct experience in Regulatory Affairs in a Medical Device Company required.
  • Knowledge and Skill Requirements / Specialized Courses and / or Training.
  • Strong interpersonal and communication skills.
  • Proficient in Microsoft Office.
  • Advanced written communication skills.
  • Create a job alert for this search

    Regulatory Manager • Seattle, WA

    Related jobs
    Senior Regulatory Affairs Associate

    Senior Regulatory Affairs Associate

    Fred Hutchinson Cancer Center • Seattle, WA, US
    Full-time
    Senior Regulatory Affairs Associate.Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infect...Show more
    Last updated: 30+ days ago • Promoted
    Reserve Nuclear Medicine Officer

    Reserve Nuclear Medicine Officer

    United States Army • Port Orchard, WA, United States
    Full-time
    THE ARMY HEALTH CARE ADVANTAGE As a member of the Army health care team, you’ll receive benefits that you won’t be able to get in a civilian career. Challenging Work Feel inspired with great case di...Show more
    Last updated: 14 days ago • Promoted
    Associate Manager, Regulatory Affairs

    Associate Manager, Regulatory Affairs

    Stryker • Redmond, WA, US
    Full-time
    Associate Manager, Regulatory Affairs.Stryker is seeking an Associate Manager, Regulatory Affairs to support Emergency Care! You will provide leadership, direction, and coordination for Stryker Med...Show more
    Last updated: 30+ days ago • Promoted
    Director Care Management

    Director Care Management

    Providence • Lakewood, WA, US
    Full-time
    Calling All Healthcare Visionaries!.Are you a dynamic leader with a passion for transformative healthcare delivery? Do you excel at navigating intricate challenges and driving change? If so, we hav...Show more
    Last updated: 11 hours ago • Promoted • New!
    Regulatory Affairs Associate

    Regulatory Affairs Associate

    FUJIFILM • Bothell, WA, US
    Full-time
    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 ...Show more
    Last updated: 22 days ago • Promoted
    RN Quality Program Manager - Oncology

    RN Quality Program Manager - Oncology

    Providence Health and Services • Renton, WA, US
    Full-time +1
    Quality Program Manager RN - Oncology @ Swedish First Hill.Fantastic benefits and compensation package offered by Providence that begin on your first day of employment. Join us, and find out how man...Show more
    Last updated: 7 days ago • Promoted
    Travel Charge RN - Alcohol & Addiction - $2,381 per week

    Travel Charge RN - Alcohol & Addiction - $2,381 per week

    Focus Staff • Bench Drive, WA, US
    Full-time
    Focus Staff is seeking a travel nurse RN Addiction Medicine for a travel nursing job in Aberdeen, Washington.Job Description & Requirements Specialty : Addiction Medicine Discipline : RN Start Date : ...Show more
    Last updated: 22 hours ago • Promoted • New!
    Regulatory Affairs Specialist II

    Regulatory Affairs Specialist II

    Katalyst Healthcares & Life Sciences • Seattle, WA, US
    Full-time
    Responsibilities : This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U. Europe, support of international product registrations ...Show more
    Last updated: 30+ days ago • Promoted
    Principal Regulatory Affairs Specialist

    Principal Regulatory Affairs Specialist

    Philips • Bothell, WA, US
    Full-time
    Principal Regulatory Affairs Specialist.As a critical member of the Philips Ultrasound- Regulatory Affairs Organization, the Principal Regulatory Affairs Specialist will lead and provide regulatory...Show more
    Last updated: 30+ days ago • Promoted
    Regulatory Reporting Specialist

    Regulatory Reporting Specialist

    ST Public Branding • Seattle, WA, US
    Full-time
    Regulatory Reporting Specialist.Under general direction from the Director of Hazard Mitigation Implementation, the Regulatory Reporting Specialist plans, manages, develops, and oversees regulatory ...Show more
    Last updated: 6 days ago • Promoted
    Active Nuclear Med Officer

    Active Nuclear Med Officer

    United States Army • Bremerton, WA, United States
    Full-time
    THE ARMY HEALTH CARE ADVANTAGE As a member of the Army health care team, you’ll receive benefits that you won’t be able to get in a civilian career. Challenging Work Feel inspired with great case di...Show more
    Last updated: 30+ days ago • Promoted
    Senior Regulatory Affairs Specialist (Hybrid)

    Senior Regulatory Affairs Specialist (Hybrid)

    Stryker • Redmond, WA, US
    Full-time
    Senior Regulatory Affairs Specialist.We are currently seeking a Senior Regulatory Affairs Specialist to join our Medical Division to be based Hybrid in Redmond, Washington.As part of the Medical Re...Show more
    Last updated: 30+ days ago • Promoted
    Travel MRI Technologist

    Travel MRI Technologist

    Prime Time Healthcare • Enumclaw, WA, US
    Full-time
    Prime Time Healthcare is seeking a travel MRI Technologist for a travel job in Enumclaw, Washington.Job Description & Requirements. Prime Time Healthcare is a leading provider of traveling healt...Show more
    Last updated: 6 days ago • Promoted
    Per Diem (PRN) Pediatrics RN

    Per Diem (PRN) Pediatrics RN

    Aya Healthcare • Snohomish, WA, US
    Full-time
    You’re one step away from freedom and flexibility around your current schedule.We have immediate per diem (PRN) shifts available for the following position : Pediatrics Registered Nurse in Edm...Show more
    Last updated: 6 days ago • Promoted
    Travel Charge RN - Alcohol & Addiction - $2,006 per week

    Travel Charge RN - Alcohol & Addiction - $2,006 per week

    GLC On-The-Go • Bench Drive, WA, US
    Full-time
    GLC On-The-Go is seeking a travel nurse RN Addiction Medicine for a travel nursing job in Aberdeen, Washington.Job Description & Requirements Specialty : Addiction Medicine Discipline : RN Start Date...Show more
    Last updated: 1 day ago • Promoted
    Travel Charge RN - Alcohol & Addiction - $2,542 per week

    Travel Charge RN - Alcohol & Addiction - $2,542 per week

    Wellspring Nurse Source • Bench Drive, WA, US
    Full-time
    Wellspring Nurse Source is seeking a travel nurse RN Addiction Medicine for a travel nursing job in Aberdeen, Washington. Job Description & Requirements Specialty : Addiction Medicine Discipline : RN ...Show more
    Last updated: 22 hours ago • Promoted • New!
    Physical Therapist, Clinic Manager

    Physical Therapist, Clinic Manager

    HealthCare Recruiters International • Belfair, WA, United States
    Full-time
    Physical Therapist, Clinic Manager, WA 125K plus sign on and relocation.Excellent opportunity for a seasoned PT to join a unique hybrid and in person model Physical Therapy practice.Our in-person c...Show more
    Last updated: 2 days ago • Promoted
    Manager State Regulatory Policy

    Manager State Regulatory Policy

    Puget Sound Energy • Bellevue, WA, US
    Full-time
    Manager State Regulatory Policy.Puget Sound Energy is looking for a Manager State Regulatory Policy to join our team.This position leads the state regulatory policy work across PSE helping the Com...Show more
    Last updated: 30+ days ago • Promoted
    Senior Vice President (SVP) of Legal & Regulatory Affairs

    Senior Vice President (SVP) of Legal & Regulatory Affairs

    InsideHigherEd • Redmond, Washington State, United States
    Full-time
    The Northwest Commission on Colleges and Universities (NWCCU) is a recognized institutional accreditor dedicated to assuring educational quality and effectiveness across higher education.Our missio...Show more
    Last updated: 10 days ago • Promoted
    Director, Quality Systems

    Director, Quality Systems

    MicroSurgical Technology • Redmond, WA, United States
    Full-time
    Founded in 1976 and headquartered in Redmond, Washington, MicroSurgical Technology's passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients a...Show more
    Last updated: 15 days ago • Promoted