Location: Skaneateles Falls,NY, USA
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.
Your Role At Baxter
This role will be responsible for global strategic planning of the portfolio within a business unit including development, implementation and management of plans and standards. Lead, mentor, and developsothers in service of Baxter's objectives in alignment with FLC's Cardiology and Respiratory Health segments. Responsible for all aspects of regulatory strategy for the respiratory health and diagnostic cardiology product segments. Provide quarterly regulatory intelligence impact assessments for SNG, STP and MKE. Oversee Notified Body consolidation activities for cardiology and respiratory health. Mentor staff for 510(k) submissions, EU MDR submissions, MDD certificate extensions, Life 2000 EUA transition plan and multiple RH and Cardiology NPD and sustaining projects. Provide regulatory strategy for the site consolidation and site transfers.
What you'll be doing
* Develop and implement regulatory strategy aligned with business 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 provide direct supervision of individuals including mentoring, performance management and staffing decisions
What you'll bring
* Masters and/or PhD will be an advantage.
* Minimum of 8-year experience in RA, 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
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $128,000 - $176,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. #LI-ASR2
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.
Equal Employment Opportunity
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
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