Director Of Regulatory Affairs Jobs in Washington

Job Title: SYS MANAGER REGULATORY AFFAIRS Company: Providence Health & Services Location: Renton, WA Description: SYS MANAGER REGULATORY AFFAIRS  System Manager, Regulator Affairs  Job Requisition Number:  63292  Posting Title:  System Manager, Regulator Affairs  Shift:  1 - Day Shift   Department:  GOVERNMENT AFFAIRS   Employment Status:  Full-Time   Location:  1801 LIND AVENUE SW RENTON, Washington 98057-0000  Salary Minimum:  Negotiable   Salary Maximum:  Negotiable   External Description:  Putting people first – that´s what sets us apart. At Providence Health & Services, we believe that everyone who works here has the power to touch people´s lives. Our employees are a dedicated team of professionals who connect to our mission: “As people of Providence, we reveal God´s love for all, especially the poor and vulnerable, through our compassionate service.” Providence Heath & Services, System Support Services, is recruiting for a System Manager, Regulatory Affairs, (Requisition #63292, FTE 1.0, Exempt). Located in Renton, WA, this position reports to the System Director, Public Policy and Research. GENERAL SUMMARY The System Manager is responsible for management of the Regulatory Affairs function, including research and policy analysis, implementation, and communications with internal/external audiences on priority Providence Health System issues that relate to health system operations – with special emphasis on finance, payment, and certification issues. In addition, under the general direction of the System Director, Government Affairs, this position services as the primary Providence Health & Services contact with certain federal agencies on health/financial policy issues. PRIMARY DUTIES •In collaboration with the Vice President, Government and Public Affairs, and the System Director, Public Policy and Research, identifies and executes on strategies to shape public policy development to supportthe advancement of PH&S strategic goals, as well as provide counsel to system leadership on the impact of public policy changes relative to the organization’s strategic direction. •Monitors major regulatory initiatives of key federal agencies with oversight of health care: the Department of Health and Human Services and its sub-agencies (CMS, HRSA, CDC, FDA), the Internal Revenue Service, the Department of Homeland Security and others as appropriate. Also monitors the White House regulatory policy agenda and provides counsel and information to system operations leaders and others where appropriate. •Conducts research and policy analysis, implementation, and communications with internal/external audiences on priority PH&S policy issues that relate to health system operations with a special emphasis on finance, payment, and certification issues. •Identifies potential CMS and other federal pilot programs and demonstration projects that advance Providence strategic objectives and provides information and support to leadership in evaluating and engagement with the relevant federal agency. •Provides timely research and analysis on federal regulatory issues on an “as-needed” basis for system customers. •Reviews, analyzes, and identifies relevant operational issues that would occur as a result of complex regulatory pronouncements from federal regulatory agencies and advisory bodies. Such issues include: oMedicaid and Medicare payment, including policy issuances and studies oRural hospital payment issues oHome health/nursing home/hospice payment issues oFederal budget issues oMental health issues oCertification issues oCoverage and eligibility issues •In collaboration with the System Director, Government Affairs, performs duties related to the day-to-day management of the Providence regulatory agenda, including preparation of issue briefs, testimony, and action plans that include tactics to successfully pursue Providence objectives in the rule-making processes; monitoring other health policy issues that may arise and advise whether they have become a priority; and involving Providence Health & Services leaders in the formal policy process including the filing of comments on all rules with a major impact as determined by the System Director, Government Affairs. •Develops customer-focused tools to support awareness around federal rules, to include self-service functions (including on-line resources), presentations, materials and direct guidance. •Assures that the Providence Health & Services position is effectively communicated to policymakers on major regulatory issues with a desired outcome that the final regulatory pronouncement reflects Providence goals and priorities. •Coordinates activities with relevant functional teams across the system, including Integrity and Compliance, Quality, Operations and others to help ensure compliance with regulatory changes and to communicate the detailed effect of various regulatory changes in a manner that can be implemented by responsible individuals MINIMUM QUALIFICATIONS Education: Minimum of a Master’s Degree in Health Services Administration, Law, Public Administration, Finance or the equivalent. Experience: A minimum of minimum of five (5) years of equivalent regulatory affairs management work experience, including specific experience in legislative or regulatory activities, health administration or legal research communications, or public relations; or an equivalent combination of education and experience. Must demonstrate experience and comprehensive knowledge of governmental processes and governmental relations. Certifications/Licenses: N/A KNOWLEDGE, SKILLS & ABILITIES •Willingness to participate in a team effort to “do what it takes to get the job done” to meet deadlines, handle sensitive information and adapt to shifting workloads. •Strong written and oral communication, presentation, and facilitation skills are required. •Demonstrated competency in research, writing, public speaking, and personal computer and software applications. •Demonstrated leadership, program management, communication, analytical, creative conceptual thinking, and writing skills are required. WORKING RELATIONSHIPS Successful accomplishment of the accountabilities of the position will require that the System Manager develop and maintain effective working relationships with a variety of persons both internal to the Health System and externally. Principal among them are the Vice President, Government and Public Affairs, System Director, Public Policy and Research, System Vice Presidents and Regional Chief Executives; Regional Finance, Government Affairs, and Integrity executives; agents of legislative and regulatory agencies at all levels, and representatives of other health care organizations and associations. To apply: When applying, please be sure to include a resume with cover letter indicating salary expectations. Interested persons are invited to submit a resume and salary expectations to: Internal candidates at: https://recruiter.kenexa.com/providence/cc/Home.ss?ccid=1sn5RRaP6Ig%3D External candidates at: https://recruiter.kenexa.com/providence/cc/Home.ss?ccid=bupJEdUjsTs%3D Providence Health & Services is an Equal Opportunity Employer Copyright 2006 Providence Health & Services. All Rights Reserved.

Job Title: Manager Regulatory Affairs Company: Acucela Location: Bothell, WA Description: Acucela is a clinical-stage, privately held biotechnology company focused on developing new drug therapies for blinding eye diseases such as age-related macular degeneration (AMD), Stargardt disease, diabetic retinopathy and retinopathy of prematurity, as well as dry eye.  The Company offers competitive compensation, a team-oriented environment, and career growth opportunities.   Manager Regulatory Affairs - A regular full time position is available immediately at Acucela Inc., in Bothell, Washington.  Some of the primarily responsibilities are:  Proactively solicit regulatory submittals from other departments across the Company. Assure the proper management, retention, and version control of all applicable Regulatory Affairs and product documentation including master files and amendments. Ensure that all regulatory documents are prepared in accordance with regulatory guidelines and internal standards and SOPs. Identify areas for improvement within daily functions, internal procedures, and regulatory agency interaction. Interact with project team members to define submission logistics and scheduling; coordinate priorities for submissions. Maintain a high level of expertise through reading and participation at professional seminars and workshops. Coordinate and ensure effective and timely input into the planning, agreement and generation of required documentation, and the review and compilation of dossiers, as needed, for submission from project teams.