Regulatory Affairs Program Manager III
Location: US-WA-Bothell
ID: 2024-1337
Category: Quality Assurance/Regulatory Affairs
Position Type: Full-Time
Work Model: Hybrid
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 visit www.verathon.com.
Overview
Verathon is looking for a Regulatory Affairs Program Manager III to become the newest member of our QA/RA Team located in Bothell, WA. The Regulatory Affairs Program Manager III is responsible for supporting the RA department in Bothell and in Burnaby, BC in the preparation and organization of documents supporting compliance to medical device industry regulations and corporate quality policy. This position will be responsible for establishing and maintaining regulatory, clinical, and regulatory legal files (both paper and electronic) for ease of access by department personnel and world-wide government agencies in compliance with applicable medical device world-wide regulations. This person will assist in the assembly, review and record archival for all regulatory submissions to various FDA, HC, EU and rest of world (ROW) government agencies.
Responsibilities
- Follow all policies, procedures, and standards for controlled documentation to ensure compliance with corporate document management policy.
- Responsible for the administration of the Regulatory Affairs Management Software tool.
- Provide cross-functional teams with product registration information to support global market launches, compliant distribution controls, and accountability of product registrations.
- Coordinate and track product registration programs and projects and provide periodic status updates to management.
- Work closely with Business Unit Leaders, Global Sales, and Product Marketing to ensure NPD launch planning, and Global registration renewal are in alignment with business priorities.
- Serve as Regulatory Liaison with FDA to obtain Certificates of Foreign Government and Certificates of Free Sale.
- Serve as Regulatory Liaison with external vendors to obtain Apostilles and legalization of documents necessary for international submissions.
- Monitor distributor contracts. Manage and track letters of authorization and pipeline products assigned to distribution partners.
- Track RA expenditures as related to regulatory submission fees and associated vendors.
- Effectively communicate project plans, changes, and issues on a periodic basis that have direct impact on product launch scheduling and renewal timelines.
- Work closely with Regulatory Associates and Verathon distributors to ensure new product registration, renewals, and product changes are processed timely and executed compliantly.
- Coordinate regulatory and clinical documents management and maintenance to assure clear traceability and integrity of regulatory documentation as required by applicable regulations.
- Maintain a broad awareness of the roles of immediate team members and cross-functional teams.
- Support the assembly and review of all regulatory submissions to various regulatory world-wide agencies like the FDA, HC, and EU.
- Interact with internal and external contacts to provide clear, straightforward, effective, and factual communication and information.
Qualifications
- 5+ years of experience in project management as it relates to medical device or pharmaceutical documentation/records management.
- Bachelor's degree preferred.
- Enthusiastic self-starter with excellent verbal, written, and interpersonal skills.
- Ability to professionally represent the company to medical professionals and regulators.
- Highly organized, detail-oriented mindset.
- Ability to be flexible and multi-task in a dynamically changing environment.
- Working knowledge of relational databases for purposes of planning and organization of regulatory data.
- Project management skills are required.
- Effective collaborator with department and cross-functional team members.
- Comfortable working independently with limited direction.
- Demonstrated organizational problem-solving skills, and computer literacy in Microsoft Office suite, databases, and electronic document management systems.
Salary range - $95,500- $127,400 (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).
Full-time employees who are not on a commission plan 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. For more information, please visit our complete Benefits Summary at Benefits Summary.
EEO
Research shows that women and underrepresented groups tend to apply to jobs only when they check every box on a job posting. If you're currently reading this and hesitating to click "Apply" for that reason, we encourage you to go for it! Even if you are not a match for this role, we may have another opportunity that may be a great fit.
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.
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