Associate Director, Regulatory Affairs

Baxter International Inc. • Raleigh, NC

1d • Onsite

About The Position

Responsible for global strategic planning of the portfolio within a business unit including development, implementation and management of plans and standards. Leads, mentors, and develops others in service of Baxter's objectives in alignment with PSS’s hospital bed segment. Participates in strategic LRP and AOP for Hospital Beds. Responsible for all aspects of regulatory strategy for the PSS hospital bed product segment. Provides quarterly regulatory intelligence impact assessments for Batesville, IN site. Oversee Notified Body consolidation activities for the PSS hospital bed group. Lead regulatory efforts for consistent delivery of CCS business objectives; regulatory policy and implementation; and identification and prioritization of key opportunities and risks. Mentors staff for 510(k) submissions, EU MDR submissions, MDD certificate extensions, and NPD and sustaining projects. Provide regulatory strategy for the site consolidation and site transfers.

Requirements

• Bachelors Degree required, or country equivalent
• Minimum of 8-year experience in RA or related medical device function, including at least 3-year experience managing people.
• Ability to work effectively in multinational/multicultural environment
• Management skills
• Sound basis of Scientific (Training/ Communications) knowledge
• Expert knowledge of regulations, and experience with interpretation and application
• Excellent written and verbal communication, presentation, and facilitation skills
• Strong negotiation skills and significant experience in interacting with regulatory authorities
• Established relationships with regulatory authorities
• Demonstrated ability to lead, mentor, and develop others for future growth and development
• Risk identification and problem-solving skills
• Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

• Masters and/or PhD will be an advantage

Responsibilities

• Develop and implement regulatory strategy aligned with business strategy.
• Lead FDA, EU MDR and global submission strategy.
• Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups.
• Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.
• Initiate and maintain appropriate communication within the RA function and represent Regulatory Affairs with business units and other functions.
• Act as primary contact for meetings with the regulatory authorities including the planning and leadership.
• Implement policies to ensure ongoing compliance with regulatory requirements.
• May manage regulatory budget at project level.
• Independently lead global regulatory strategy development, planning, and implementation for multiple complex programs and platforms.
• May represent Baxter interests in industry and working groups.
• Guide and influence technical groups in areas of product development.
• Assess impact of new regulations and implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance.
• Responsible for negotiating and decision making with regulators and stakeholders with complex and high-risk projects.
• May participate in potential and established third party efforts (i.e. Due diligence activities, joint ventures, etc.).
• May provide direct supervision of individuals including mentoring, performance management and staffing decisions.

Benefits

• medical and dental coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• educational assistance programs
• paid holidays
• paid time off ranging from 20 to 35 days based on length of service
• family and medical leaves of absence
• paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Manager