Mgr Regulatory Affairs-Front Line Care (FLC)
Mgr Regulatory Affairs-Front Line Care (FLC)
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$ 112000 - 154000
1 Vacancy
Job Description
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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.
Baxters 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
Responsible for defining global regulatory strategies and submissions in support of new and existing marketing authorizations for products for one or more business units/countries.
What youll be doing
Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations.
Represent or lead the RA function on assigned crossfunctional project teams.
Monitor applicable regulatory requirements; assure compliance with Baxter and external standards.
Establish appropriate communication within RA and other functions primarily at project level.
Perform gap analysis and propose solutions.
Develop and document sound regulatory decisions and justifications.
Ensure project teams and business objectives and deliverables are aligned with regulatory strategy.
May provide direct supervision of individuals.
May review promotional material or SOPs for compliance with local and global regulations.
What youll bring
Bachelors degree or country equivalent in a scientific field.
Masters and/or PhD will be an advantage.
5 years or more of experience in RA or related field (preferably medical device or pharmaceutical) including people management or projects.
Ability to work effectively in multinational/multicultural environment
Sound basis of Scientific (Training/ Communications) knowledge
Ability to oversee multiple projects in a matrix team environment
Excellent oral and written communication and presentation skills
Demonstrated excellent interpersonal and collaboration skills including diplomacy to negotiate conflicting priorities
Experience with Class II and Class III EU device is preferred
Experience with EU MDR preferred
Experience with the US 510k submissions strongly preferred
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 inperson 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 $112000 to $154000 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. This position may also be eligible for discretionary bonuses. 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.
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.
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US Benefits at Baxter (except for Puerto Rico)
This is where your wellbeing matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and wellbeing benefits include medical and dental coverage that start on day one as well as insurance coverage for basic life accident shortterm and longterm disability and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount and the 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching. We also offer Flexible Spending Accounts educational assistance programs and timeoff benefits such as paid holidays paid time off ranging from 20 to 35 days based on length of service family and medical leaves of absence and paid parental leave. Additional benefits include commuting benefits the Employee Discount Program the Employee Assistance Program (EAP) and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site: Benefits Baxter
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.
Know Your Rights: Workplace Discrimination is Illegal
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.
Required Experience:
Manager
Employment Type
Full-Time
