Verathon, Inc.
Senior Regulatory Affairs Specialist
Bothell ,
Washington
Apply Now
Senior Regulatory Affairs Specialist - VerathonVerathon is seeking a highly experienced and motivated Senior Regulatory Affairs Specialist to join our dynamic QA/RA Team in Bothell, WA.
As a key member of our team, you will play a crucial role in managing product approvals on a global scale.
This is an exceptional opportunity for an individual who thrives in a fast-paced environment and possesses extensive regulatory knowledge.This is a hybrid role, working 3 days a week in the office (Monday, Tuesday, Thursday).Principal Responsibilities:
Manage regulatory strategies for the worldwide device listing and registration of Verathon products in accordance with product development and business objectivesEnsure compliance with all applicable regulatory or clinical standards governing Verathon, Inc.
productsPlan, develop, prepare, and obtain timely approval for product submissions to FDA and other worldwide regulators for Verathon\'s productsMentor an internal team of Regulatory associates, contracted clinical study, medical professionals or other consultants to achieve department and corporate objectivesManage the review and approval of product design, manufacturing and quality assurance changes and marketing advertising and promotional materialsEnsure compliance with internal procedures, applicable regulations and guidelines, local country registration requirements, and FDA\'s Quality System Design Control and labeling requirementsServe as key leadership team member in cross-functional program teamsProvide clear and consistent regulatory guidance to facilitate timely delivery of leading-edge products and services to Verathon customersKnowledge, Skills, and Abilities:
Capable, confident individual contributor with 10+ years of experience and a BA or 8+ years of experience and a MS/MBAWorking knowledge of all FDA submission requirements; including 510(k), Q-Submission, IDE/IRB Clinical submissionsSubject Matter Expert in design dossiers and design history file content to ensure design documentation is adequate to support regulatory submissionsKnowledgeable and skilled core team regulatory affairs representative to ensure regulatory requirements are fulfilled and adequateMust be proficient in all areas of international regulatory requirements, including AU, NZ, China, Japan, EU, EE, and Middle East countriesOversee registration and distribution tools required to track and streamline world-wide regulatory approvalsWorking knowledge of both direct and distributor models needed to support international registrationsMust be familiar with distribution agreements, language requirements; and country specific MOH requirements for new product registrations and on-going renewalsMust possess excellent \"situational\" leadership skills with ability to work highly effectively in cross-functional teams and must thrive in a dynamic, fast-paced environmentMust have exceptional writing, verbal, and interpersonal skills with internal and external stakeholdersRequired to maintain positive, collaborative relationships with all regulatory agencies with whom Verathon\'s products are regulatedAssist with the growth and development of lower-level regulatory affairs professionals to sustain a productive and positive working environmentIf you\'re currently reading this and hesitating to click \"Apply\" because you don\'t check all the boxes, we encourage you to go for it! A true passion and excitement for making an impact is just as important to us as work experience.Join Verathon and be part of our dedicated team as we continue to make a difference in the healthcare industry.
We offer a supportive work environment that encourages professional growth and achievement.
Apply today to take your regulatory affairs career to the next level!Salary range - \$112
•
United States - WA - WA - Renton
June 27, 2024
Entity: • Production & Operations Job Family Group: • Operations Group • The Pipeline Controller plays a key role in monitoring, conducting, and maintaining safe and efficient pipeline operations in accordance with Department of Transportation (DOT) regulatory requirements. This position requires...
United States - WA - WA - Mount Vernon
March 18, 2024
1012 • The information described in this job description has been designed to indicate the general nature of the work performed. • It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned...
United States - WA - WA - La Conner
June 7, 2024
Thur, Fri, Sat Sun and Fri, Sat, Sun every other week Must be familiar with Dementia. Join our team where you are valued and understood! The impact you have as a professional caregiver makes a lifelong difference! Full time and Part time available- great opportunity if you want to manage your own...
United States - WA - WA - Malaga
July 2, 2024
About the facility A corrections facility is seeking a Family DNP for locum tenens coverage. About the facility location In Western WA, you can visit the iconic Space Needle in Seattle for panoramic views of the city and Puget Sound. Additionally, explore the lush landscapes of Olympic National Park...
United States - WA - WA - Seattle
July 2, 2024
Year Up is a one-year or less, intensive job training program that provides young adults with in-classroom skill development, access to internships and/or job placement services, and personalized coaching and mentorship. Year Up participants also receive an educational stipend. The program combines...
United States - WA - WA - Redmond
July 2, 2024
JOB DESCRIPTION: $80K-$110KSEEKING INDUSTRIAL COATINGS SUPERINTENDENTSGPAC: #1 Industrial Coatings Recruiting Firm in North America: WORK FOR A LEADING CONTRACTOR • I am working with a well-respected, firmly established Industrial Coatings Contractor seeking experienced Superintendents. This is an...
United States - WA - WA - Malaga
July 2, 2024
About the facility A facility is seeking an urgent care physician for locum tenens coverage. About the facility location While in Spokane, Washington, check out the numerous outdoor recreation options, the abundance of nightlife, or dive into the arts and culture scene with shows and museums. The...
Yakima Valley Farm Workers Clinic
United States - WA - WA - Kennewick
January 11, 2024
At Yakima Valley Farm Workers Clinic, we believe you're more than a Dental Assistant, and we are more than a job. We're an FQHC committed to providing patient-centered care to communities. Compassion is at the core of our approach. We treat patients according to their preferences, regardless of...
United States - WA - WA - Seattle
July 2, 2024
The Shrapnel team is seeking bright minds from every culture, discipline, and background to join us on a new creative endeavor. • We're a mission-focused team with industry roots in world-class game development, studio building, and platform creation. • Our goal is empowering the world to share in...
United States - WA - WA - Seatac
July 2, 2024
JOB DESCRIPTION: $80K-$110KSEEKING INDUSTRIAL COATINGS SUPERINTENDENTSGPAC: #1 Industrial Coatings Recruiting Firm in North America: WORK FOR A LEADING CONTRACTOR • I am working with a well-respected, firmly established Industrial Coatings Contractor seeking experienced Superintendents. This is an...
United States - WA - WA - Ferndale
July 2, 2024
Description • Summary: To supervise Reef Rewards employees to ensure proper procedures are adhered to and to manage their time. They will assist the Reps in enrolling new Reef Rewards members, assist all members in new promotions and sell concert tickets. • Qualifications: • Excellent management...
United States - WA - WA - Malaga
July 2, 2024
About the facility A large hospital, part of a large health system is seeking a hematologist/oncologist for locum tenens coverage. About the facility location Explore Riverfront Park with its iconic Spokane Falls and Pavilion attractions. Discover the vibrant arts scene at the Northwest Museum of...
United States - WA - WA - Union
June 11, 2024
Hiring Full-Time Caregivers (PCA/HHA/CNA/Companions) - Flex Schedules Openings for caregivers to work within a home care or assisted living setting.We are an approved training site welcoming experienced caregivers and individuals with a caring heart that would like to learn how to care for the...
United States - WA - WA - Mount Vernon
July 3, 2024
Care Professional - Home Care Aide Do you desire to work for an organization where personal growth and development are a top priority? Are you interested in working with a vulnerable population where you can make a difference in the lives you serve while feeling confident that you have the skills...
United States - WA - WA - Dayton
June 30, 2024
CDL A Regional - Flatbed 1450 Minimum. Company Flatbed Drivers Average $1,450 Minimum Pay! Weekly Gross • 3 Months Verifiable CDL A Experience with No More Than 3 Jobs in The Last Year* • • As a home-weekly driver, you will operate regionally, pulling 48 ft. flatbed trailers. • Pay and Bonus...
United States - WA - WA - Malaga
June 20, 2024
About the facility A facility is seeking a gastroenterologist for locum tenens coverage. About the facility location Discover the rich agricultural heritage of the Yakima Valley with visits to local wineries, orchards, and farms. Explore the outdoor beauty of nearby destinations like Mount Rainier...
United States - WA - WA - Seattle
June 27, 2024
Get in touch with a Weatherby consultant today to learn more about this and other opportunities available now. • BC or BE required • Weekdays, Days • Clinic only • 20 patients per day in clinic, 7 patients per day in hospital, 5 deliveries per physician per week • Credentialing needed • DEA needed •...
EcoPlanet Green Operations GmbH
United States - WA - WA - Bothell
July 2, 2024
Job Title: Senior Specialist, Quality Assurance • Location: Bothell, WA* 100% Onsite • TOP SKILLS* • 5-8 years of experience in oversight and execution of deviation initiation, investigations, and approvals within a quality management system. • Demonstrated ability to work cross-functionally and to...
United States - WA - WA - Malaga
June 28, 2024
About the facility A multifaceted healthcare organization with a full range of OBGYN services is seeking an OB/GYN for locum tenens coverage. About the facility location The facility is located in Moses Lake, WA. About the clinician's workday The schedule is 24-hour beeper call. Additional job...
United States - WA - WA - Walla Walla
June 28, 2024
Front Office Receptionist Inland Family Dentistry is looking for an Office Receptionist to join our team. Why Heartland Dental? Heartland Dental believes that to provide exceptional lifetime care for patients, we must hire and grow team members who will support the business and clinical needs of...
United States - WA - WA - Bothell
July 2, 2024
Shift Schedule is 2100-0730, Wednesday-Saturday • The Quality Associate II position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (Jump). • Primary Responsibilities include the review of cGMP Controlled Documents such as SOPs, Forms, completed batch...
United States - WA - WA - Malaga
July 2, 2024
About the facility A facility is seeking a gastroenterologist for locum tenens coverage. About the facility location Elma, WA offers a range of fun activities for visitors. You can explore the scenic beauty of Vance Creek County Park, which features walking trails, fishing spots, and picnic areas....
United States - WA - WA - Paradise Inn
June 16, 2024
Work can be performed by a Nurse Practitioner.We are looking for the right Nurse Practitioner to perform medical assessments on United States Veterans as part of the VA's disability benefits process.In performing Disability Assessments, you will review medical records electronically through a web...
Provider Solutions and Development
United States - WA - WA - Bothell
July 2, 2024
Nurse Practitioner physician employment in Washington : • Join the compassionate team at Pacific Medical Centers' Canyon Park clinic as a Primary Care Nurse Practitioner with part-time or full-time flexibility. • This practice is known for serving the community and has a dedicated team of providers,...
Yakima Valley Farm Workers Clinic
United States - WA - WA - Kennewick
April 18, 2024
Join our team as an on-call Registered Nurse at Miramar Health Center in Kennewick, WA, and be part of a healthcare organization that believes in making a difference beyond medical care! At Yakima Valley Farm Workers Clinic, we believe you are more than a nurse, and we are more than a job! We value...
United States - WA - WA - Port Hadlock
June 14, 2024
Luxury Assisted Living Jobs - Resident Caregivers & CNAs Offering full-time and part-time positions at large assisted living company in America.Rated as top place to work!Looking to join a leader in Assisted Living to grow your career?We employ thousands of associates nationwide and we're hiring our...
United States - WA - WA - Pacific
June 28, 2024
Work can be performed by a Nurse Practitioner.We are looking for the right Nurse Practitioner to perform medical assessments on United States Veterans as part of the VA's disability benefits process.In performing Disability Assessments, you will review medical records electronically through a web...