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Senior Director Regulatory Affairs, Front Line Care business unit (Class II and Class III medical devices)

Req # 22122141 Location Skaneateles Falls, New York, United States Job Category Regulatory Affairs Date posted 01/14/2022

Hillrom and Baxter have united, creating one of the world’s leading medical products companies. We are committed to our shared vision to transform healthcare. We're building on the legacy and strengths of two historically innovative and socially responsible companies that—when joined together—should better serve our patients, customers and communities. This is an exciting time to join us as we begin a new chapter, together.


No matter your role at Baxter, your work makes a positive impact on people around the world. You can expect to work with caring people who value relationships. Our teams are strong and empowered because we value differences. This is where you can do your best work and thrive in an international environment. This is where you can belong.


THE ROLE:

The Front Line Care (FLC) business unit products enable earlier diagnosis and treatment. The sooner the diagnosis — the more options for effective treatments. Our smart screening devices and diagnostic tools empower clinicians and health systems to identify and treat every patient with confidence, shortening the path to assessment and then to care.  The portfolio includes products for vision screening & diagnostics which focus on preventing blindness by facilitating early detection and treatment; physical exam & diagnostic tools; diagnostic cardiology connected electrocardiograph products; and respiratory care portfolio.

The Senior Director Regulatory Affairs, Front Line Care Business Unit is responsible for global strategic direction and performance (strategy and execution) of the RA function within the $1+B business unit including development, implementation and management of global regulatory strategies and proactively influencing and shaping the regulatory environment in support of business goals and strategies.  The Senior Director will interface with a variety of management levels on significant matters, often requiring the coordination of activity across multiple functions, and at times, across different GBUs.

S/he will manage all regulatory activities associated with the four primary FLC businesses including Vision Care, Respiratory Health, Cardiology and Physical Exam and Diagnostics (complex Class II and Class III medical devices with embedded software). S/he also participates in the FLC Leadership Team to communicate regulatory objectives and activities, regulatory risks and key topics, regulatory guidance for NPD and product changes, as well as to align RA priorities with the business objectives. 

REPORTING RELATIONSHIPS:

The Senior Director reports to the Vice President, Global Regulatory Affairs.  The Senior Director has a team of approximately 20.  S/he collaborates and interfaces with other GBU and regional RA, marketing, NPD R&D, sustaining engineering, business operations, service, sales, corporate engineering, FLC cross-functional Leadership Team, etc.  The Senior Director is a member of Regulatory Affairs Leadership Team (RALT).

LOCATION:

The role is located in beautiful upstate New York in a bedroom community outside of Syracuse, Skaneateles Falls.  The manufacturing facility in Skaneateles Falls, NY is Welch Allyn brand of medical devices are manufactured.  Relocation will be provided. 

BASIC FUNCTION AND PRINCIPAL RESPONSIBILITIES:

• Proactively develop new innovative approaches

• Accountable for alignment of regulatory strategy to business strategy across all functional areas

• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with members of Regulatory and other cross-functional teams

• Accountable for regulatory strategy and vision within the business unit

• Identify risk areas within the global business unit and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans working with cross-functional partners

• Negotiate and interact with the regulatory authorities including the oversight, planning and leadership of meetings

• Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global registrations

• Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements

• Develop and manage budget for the business unit RA group

• Recruit, develop and lead a team of regulatory professionals in development of strategic plans and regulatory submissions

• Oversee team management and development

• Engaged in policy development within organization and with external groups

• Guide proactive relationships with regulatory authorities to facilitate interactions for critical issues

• Influence the direction of the regulatory function; ensure development of competencies and capabilities for current and future goals

•  25% travel


EDUCATION AND EXPERIENCE:

• Bachelor’s degree is required; Advanced degree or country equivalent; Masters and/or PhD will be an advantage

• Minimum of 12 years experience in Regulatory Affairs; experience with Class II or Class III medical devices ideal

• Minimum of 7 years of leadership experience to ensure team engagement; recruiting, hiring and retaining the best candidates; managing employee performance; as well as mentoring and providing guidance to the team

• International experience/exposure preferred

• Exercises judgement independently

• Ability to work effectively in multinational/multicultural environment

• Sound basis of Scientific (Training/ Communications) knowledge

• Excellent written and verbal communication, presentation, and facilitation skills

• Expert knowledge of regulations, current industry practices, and strong experience with interpretation and application

• Extensive familiarity with Industry and knowledge of forces impacting function

• Ability to lead, mentor, and develop others for future growth and development

• Proven negotiation skills and significant experience in interacting with regulatory authorities

• Established credibility with regulatory authorities

• Expert risk management skills

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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