Senior Engineer - Regulatory Affairs
Senior Engineer - Regulatory Affairs
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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 liveswhere your purpose accelerates our mission.
Job Title: Sr Engineer Regulatory Affairs
For us working at Baxter is not just a jobits a calling. Our mission to save and sustain lives unites us.
We are driven not by what will be easy but what will transform global healthcare for generations to come. Together we create a place where we are happy successful and inspire each other as we pursue rewarding careers.
Were grateful youre interested in continuing your career journey with Baxter. This is where your purpose accelerates our mission and make a positive impact on millions of people around the world.
JOB SUMMARY:
This role is responsible for providing regulatory support for on-market products. You will be independently Plan Organize and Execute activities include change assessment variation planning creation of submission documentation identification of local submission requirements product/facility change management process support and participation in project sub-teams.
You will help accelerate the design and development cycle by collaborating across cross functional team.
Will be guiding supporting and mentoring the team who are part of engineering design development and V&V.
This position is based out of Bangalore and reporting to the Manager Systems - Patient Support Systems and Global Surgical Solutions divisions.
Essential Duties and Responsibilities:
Review and provide regulatory impact assessments for changes
Support global submission deliverables for product variation submissions
Responsible for working with other parts of the regulatory organization to achieve desired results.
Execute global plans and regulatory submission deliverables for sustaining variations
Utilize regulatory knowledge to prepare submission deliverables that will achieve desired results
Ensure identified standards and content requirements are met for regulatory submissions
Timely actively support query responses
Engage with Global Business Unit Regulatory teams and Regional Regulatory teams to ensure regulatory activities are in alignment with business requirements
Interface and align with other regulatory affairs sub-functions to provide seamless regulatory support to the project sub-team(s).
Maintain regulatory files in a format consistent with requirements
Tracking of status quality/compliance and progress of regulatory documentation
Review edit and proofread regulatory documentation
Work closely with product development clinical and marketing teams to gain required information for new product submissions and provide regulatory input to project teams as required (Example: DHF remediation labeling guideline)
Assist with the review of documents including risk analysis FMEA reports labeling advertising promotion and marketing literature
Assist with document control including document review approval archiving maintenance of document list and working with other functional groups on development of new processes or procedures
Maintain regulatory files in a format consistent with requirements
Assist with the writing and coordination of regulatory submissions for both developed and emerging countries/regions including original IDE original PMA and 510(k) submissions and supplements EU Design Dossiers and Technical Files Canadian Device License Applications etc.
Your Team:
This position will be reporting to the Manager Systems - Patient Support Systems and Global Surgical Solutions divisions. This position does not have any direct reports. You will need to work collaboratively with R&D and cross functions.
Your Location:
The role is in Baxter R&D facility in Bangalore India.
What Youll Bring:
Bachelors Degree with 6 years or Masters with 3years experience in Bio-medical engineering Electrical Engineering Electronics Engineering Software Engineering Computer Science Mechanical Engineering Industrial Engineering or related field
Experience practitioner in basic engineering function of Medical device
Experience in Medical Device development FDA Regulations and MDR.
Strong interpersonal skills with the ability to collaborate with others in a team environment
Understanding of and adherence to FDA ISO and IEC design control procedures regulations and standards.
Able to deliver on multiple projects simultaneously
Knowledge of regulations and ability to communicate and apply
Ability to identify compliance risks and escalate when necessary
Excellent verbal and written English communication skills suitable for multi-location working relationships
Demonstrated teamwork and collaboration skills
Aptitude for Mindfulness and attention to detail
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.
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:
Senior IC
Employment Type
Full-Time
