The Senior Director is responsible for ensuring policies and procedures are adhered to across the standards department, resulting in high quality and consistent standards. This position also works closely with AAMI members, industry leaders, government representatives and subject matter experts (SMEs) across the field to develop standards and related products that solve challenges impacting multiple facets of the health/medical device industry.
Duties & Responsibilities
- Oversee the AAMI Standards Board (SB) and its associated activities, including but not limited to:
- Plan and execute meetings (in person and virtual) of the SB.
- Lead the maintenance, revision, and implementation of the AAMI Standards Program Policies and Procedures and related training materials (both internal and external). This includes successful reaccreditation of any revised policies by ANSI.
- Lead the annual or biannual co-chair rotation management.
- Consult with Directors on the development of new work item proposals (NWIP’s) to ensure success at SB; this includes reviewing forms and supporting documentation and ensuring that proposed projects are in alignment with the strategic plan.
- Monitor the growth of all standards program areas and work collaboratively with the SB and across the department to address potential challenges and opportunities.
- Develop and ensure implementation of quality control processes across the department, including but not limited to:
- Develop plan and supporting process for the conduct of an annual AAMI self-audit.
- Review and approve all ANSI forms that are to be submitted.
- Ensure that proper outreach is being carried out as required AAMI and ANSI.
- Provide guidance to AAMI staff overseeing the Standards Monitor Online etc., to ensure appropriate information is being disseminated and in a timely manner.
- Spot check documents to ensure proper format, elements, etc. have been adhered to prior to submission to production for review/editing.
- Ensure high levels of data quality with periodic analysis of the overall work in progress and publications as listed in standards project development software platform to ensure that the information is current and accurate; this includes alignment with ANSI, ISO, and IEC records.
- Lead development of consistent communications of standards information (i.e., emails for ballots) from AAMI to consensus bodies.
- Lead informational sessions with the entire standards team to keep them apprised of changes to any policies and procedures that will affect the entire program.
- Attend meetings/workshops (in person and virtually) led by ANSI/ISO to continuously stay apprised of changes in ANSI/ISO processes.
- Lead and mentor direct reports.
- Work closely with and provide oversight as appropriate to committees and working groups in the development of national (AAMI, ANSI) and international (ISO/IEC) standards ensuring all relevant policies and procedures are followed.
- Liaise with and represent AAMI, its policies and values to all stakeholders at committee, working group and other relevant meetings as appropriate.
- Convene and advise members of the publications, marketing, and education staff on the ongoing status of standards to ensure the appropriate and timely coordination of the production, promotion and marketing of standards and related or derivative products.
- Collaborate with membership in recruiting and retaining corporate members to achieve budgeted corporate membership revenue targets.
- Respond to written, electronic mail, and telephone inquiries regarding standards.
- Develop reports, articles, etc.as requested by VP or other AAMI staff.
- Provide budget input as requested by VP.
- Other duties as assigned.
- Bachelor’s degree required. Advanced degree preferred.
- Strong communication (both written and oral), leadership and interpersonal skills required.
- Exceptional project management and organizational skills with ability to manage multiple priorities simultaneously required.
- Experience managing volunteer committees within a membership organization highly desirable.
- Minimum of 5-7 years’ relevant experience desired.
- Knowledge of U.S. and international standards systems is highly desirable
- Strong commitment to teamwork, transparency, and collaboration.
- Technologically savvy. Must be proficient in Microsoft Office Suite and web-based platforms.
- Able to travel domestically and internationally (approximately 20%).
- Working conditions are an office environment.
- Occasional weekend/evening work required.
- Currently working remotely due to COVID-19 until further notice