- Perform internal audits to determine compliance with Quality Management System standards, policies, and procedures, as well as regulatory and customer requirements under the direction of the Sr. RC Specialist
- Assist the Sr. RC Specialist in generating audit reports, tracking responses, recommending corrective action plans, and verifying implementation effectiveness of QMS corrective and preventive actions
- Prepare and/or coordinate regulatory field action assessments (e.g. Health Hazard Evaluations) following established procedures
- Provide support for FDA and other governmental or ISO Notified Body inspections, including pre- and post-inspection support
- Assist with corrective action and remediation plans, as necessary under the direction of the Sr. RC Specialist
- Investigate and develop solutions to procedure and process-related issues
- Consult with management and cross-functional partners to help formulate and implement proactive regulatory compliance strategies and controls
- Participate and lead project teams to improve processes at both local and global levels
- Assist in the execution and distribution of standard metric reports, preparation of compliance input for management reviews, maintains company compliance scorecard and related documentation
- Bachelor's Degree in a Scientific or Engineering field or equivalent work experience
- 2+ years' experience in a Food and Drug Administration or equivalently regulated environment
- Knowledge of QSRs, ISO 13485, MDR, CMDR, TGA, and JPAL requirements is required
- Certified Lead Auditor strongly preferred (ASQ CQA)
- Knowledge of Design Controls and Sterilization preferred
- Experience supporting external audits such as FDA, Notified Body, or customer audits preferred
- Able to complete regulatory reports and provide written correspondence to internal and external customers including regulatory bodies
- Must have excellent oral and written communication skills. Must have the ability to handle confidential data.
- Experience or training in Process Excellence and Six Sigma tools and methodologies preferred
- Must be a critical thinker, detailed oriented with strong problem-solving skills, able to oversee multiple tasks for several projects or base business deliverables, and effectively balance priorities
-
Manufacturing Compliance Specialist
1 week ago
Theery Woodinville, United StatesSummary: · The Manufacturing Compliance Specialist is responsible for manufacturing quality deliverables such as deviation investigations, trend assessments, CAPA, batch record review, and change controls. Additionally, the Manufacturing Compliance Specialist serves as a mentor ...
-
Manufacturing Compliance Specialist
1 week ago
Medix™ Woodinville, United StatesManufacturing Compliance Specialist · Location: Woodinville, WA · Pay: $33 - $38/hour · Schedule: Monday - Friday · Summary: · The Manufacturing Compliance Specialist ensures the quality of manufacturing deliverables, including deviation investigations, trend evaluations, CAPA, b ...
-
Manufacturing Compliance Specialist
1 week ago
Medix™ Woodinville, United StatesQualifications · Minimum of associate's degree and/or equivalent combination of education and experience is required · 2+ years of experience in a GMP Quality or Manufacturing setting · Extensive knowledge of SOPs and cGMPs and the know–how to work and manage within a regulated e ...
-
Manufacturing Compliance Specialist
2 weeks ago
Inventprise Inc. Woodinville, United StatesJob Description · Job DescriptionSalary: $ $38.00 / Hr DOE · Title: Manufacturing Compliance Specialist · Overtime Status: Non-Exempt · Employment Status: Full-Time · Pay Range: $ $38.00 /hourly DOE · The hiring pay range for this position is $ $38.00 per hour based on skills, e ...
-
Manufacturing Compliance Specialist
4 weeks ago
Inventprise Inc. Woodinville, United StatesJob Description · Job DescriptionSalary: $ $38.00 · Title: Manufacturing Compliance Specialist · Overtime Status: Non-Exempt · Employment Status: Full-Time · Pay Range: $ $38.00 /hourly DOE · The hiring pay range for this position is $ $38.00 per hour based on skills, education, ...
-
Compliance Specialist II
2 weeks ago
Verathon Bothell, United StatesCompany Overview · Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted pat ...
-
Manufacturing Compliance Specialist
1 week ago
Medix Woodinville, United StatesQualificationsMinimum of associate's degree and/or equivalent combination of education and experience is required2+ years of experience in a GMP Quality or Manufacturing settingExtensive knowledge of SOPs and cGMPs and the know-how to work and manage within a regulated environmen ...
-
Manufacturing Compliance Specialist
1 week ago
Medix Woodinville, United StatesQualifications · Minimum of associate's degree and/or equivalent combination of education and experience is required · 2+ years of experience in a GMP Quality or Manufacturing setting · Extensive knowledge of SOPs and cGMPs and the know-how to work and manage within a regulate ...
-
Manufacturing Compliance Specialist
5 days ago
Theery Woodinville, United StatesSummary: · The Manufacturing Compliance Specialist is responsible for manufacturing quality deliverables such as deviation investigations, trend assessments, CAPA, batch record review, and change controls. Additionally, the Manufacturing Compliance Specialist serves as a mentor ...
-
Manufacturing Compliance Specialist
4 weeks ago
Inventprise LLC Woodinville, United StatesJob Description · Job Description Salary: $ $38.00 · Title : Manufacturing Compliance Specialist · Overtime Status: · Non-Exempt · Employment Status: · Full-Time · Pay Range: · $ $38.00 /hourly DOE · The hiring pay range for this position is $ $38.00 per hour based on ski ...
-
Compliance Specialist
2 weeks ago
humangood Seattle, United States Full timeJob Details · Description · This position develops, monitors, and maintains HUD and Tax Credit and other regulatory occupancy compliance at the affordable housing communities under the supervision of the Senior Compliance Specialist and Director of Compliance. · Perform file a ...
-
Roving Compliance Specialist
1 week ago
Indigo Real Estate Services Bellevue, United StatesCompliance Specialist - Affordable Housing · Company Overview · At Indigo Real Estate, we attribute much of our properties' successes to the strengths of our team members and we are seeking a Compliance Specialist who is proficient in tax credit paperwork and driven to succeed. ...
-
Roving Compliance Specialist
1 week ago
Indigo Real Estate Services Bellevue, United StatesCompliance Specialist – Affordable Housing · Company Overview · At Indigo Real Estate, we attribute much of our properties' successes to the strengths of our team members and we are seeking a Compliance Specialist who is proficient in tax credit paperwork and driven to succeed. ...
-
Roving Compliance Specialist
2 weeks ago
Indigo Real Estate Bellevue, United StatesJob Description · Job DescriptionCompliance Specialist – Affordable Housing · Company Overview · At Indigo Real Estate, we attribute much of our properties' successes to the strengths of our team members and we are seeking a Compliance Specialist who is proficient in tax credit p ...
-
Affordable Compliance Specialist
3 weeks ago
Equity Residential Seattle, United StatesJob Description · The Affordable Compliance Specialist ("ACS") reports to an Affordable Compliance Manager ("ACM") and is primarily responsible for all aspects of the affordable housing programs associated with the communities in their assigned portfolio. Programs may include Lo ...
-
Security Compliance Specialist
2 weeks ago
Pinkerton Seattle, United StatesWe are as invested in your career as you are. As you navigate through these uncertain times, know that Pinkerton has been a stable, thriving corporation for over 170 years. As recognized leaders around the globe in the corporate risk management industry, you can rest assured that ...
-
Compliance Specialist Hybrid
3 weeks ago
Providence Health & Service Everett, United StatesProvidence caregivers are not simply valued theyre invaluable. Join our team and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to i Compliance Specialist, Complianc ...
-
Compliance Specialist Hybrid
2 weeks ago
Providence Health & Services Everett, United StatesProvidence caregivers are not simply valued - they're invaluable. Join our team and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and retain the best peo ...
-
Compliance Specialist Hybrid
3 weeks ago
Providence Swedish Everett, United StatesDescription · Providence caregivers are not simply valued - they're invaluable. Join our team and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and reta ...
-
Compliance Specialist Hybrid
2 weeks ago
Providence Health & Service Everett, United StatesJob Description · Providence caregivers are not simply valued - they're invaluable. Join our team and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and ...
Compliance Specialist II - Bothell, United States - Verathon
Description
Company Overview
Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility.
Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management.
The company's BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients.
Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific.
For more information, please visitOverview
Verathon is looking for a Regulatory Compliance Specialist to become the newest member of our QA/RA Team located in Bothell, WA.
The Regulatory Compliance Specialist is responsible for assuring the Quality Management System is maintained in a state of readiness to applicable regulations and directives such as FDA 21CFR820; ISO 13485; EU Medical Device Regulations (MDR); Canada Medical Device Regulation (CMDR); Australia Therapeutic Goods Act (TGA); Brazil National Health Surveillance Agency (ANVISA); Japan Pharmaceutical Affairs Law (JPAL); and to corporate standards as applicable.
ResponsibilitiesIf this position is filled outside the Seattle WA metro area, this salary range will vary depending on the specific hiring location.)
Full-time non-sales employees are eligible for Verathon's annual bonus plan based on company and individual performance.
Verathon provides a competitive benefits package including medical, dental, vision, basic life insurance, paid holidays, paid time off and a 401(k) matching plan.
EEO
Verathon is an equal opportunity employer and strongly supports diversity in the workplace. We believe that diverse ideas, opinions and perspectives will build a strong foundation for success.
In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Verathon will be based on merit, qualifications, and abilities.
Verathon does not discriminate in employment opportunities or practices on the basis of race, color, religion, sexual orientation, gender identity, national origin, age, disability, or any other characteristic protected by law.
