New · posted Nov 8
Baxter · Medical Devices
Global Regulatory Affairs Publishing Specialist
- Round Lake, IL
- Hybrid
- Full-time
- Associate & Specialist
The role
This is where your work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
What you need
What you'll bring
- Bachelor’s degree or equivalent combination of education and relevant professional experience.
- 1-3+ years of regulatory publishing or regulatory operations experience in the pharmaceutical or medical device industry would be an advantage.
- Hands on experience with pharmaceutical submissions and eCTD (INDs, BLAs. NDAs, ANDAs) and device submissions (eCopy and eStar)
- Experience in electronic publishing/document/data management systems (e.g. Veeva/RIM, ISI Toolbox, eCTD Xpress)
- Familiarity with electronic submission regulations and guidance, including 21 CFR Part 11.
- Sound basis of Regulatory knowledge
- Ability to manage complex projects and timelines in a matrix team environment
- Strong oral and written communication and presentation skills
- Demonstrated interpersonal skills including strong negotiation skills
- Ability to independently identify compliance risks and escalate when necessary
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 $72,000 - $99,000 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.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.
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.
What you'll do
Your role at Baxter
As a Global Regulatory Publishing Specialist, you will play a critical role in bringing life-saving products to patients by ensuring regulatory submissions are prepared, published, and delivered accurately and on time across global markets. In this role, you'll collaborate with cross-functional teams to support product registrations and lifecycle management activities while maintaining compliance with evolving health authority requirements and electronic submission standards.
- Manages the preparation of regulatory submissions for major markets such as US, EU, Canada, Australia and other global regions.
- Perform technical validation and resolve publishing errors before dispatch.
- Support initial applications and lifecycle submissions.
- Drives integration and transition of products into regulatory operation processes.
- Compile technically compliant submission components and manage document formatting.
- May represent Global Publishing on project teams driving timelines for submission document deliverables.
- Partner closely with functional peer groups inside and outside the department.
- Provides system and process support, development, and training when necessary.
Pay
$72,000 – $99,000 a year
Employer providedThis is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term 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 time-off 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 employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Where you'll work
Round Lake, ILHybridOpen in Maps (opens in a new tab)
More jobs in Round Lake, ILEqual opportunity, accessibility and legal noticesBaxter's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% above the US median for Regulatory Operations roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US9 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $72,000 | — | $99,000 |
| All US (middle half) | $75,500 | $85,000 | $90,500 |
This role: Baxter's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Operations
The general path across 41 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Baxter's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions7
- Collaboration and leadership7
- GMP and compliance3
- Documentation and SOPs3
- Data and digital systems2
- Validation and qualification1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Operations work in medical devices, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA eSTAR(official source, opens in a new tab)The electronic submission template for 510(k) and De Novo requestsNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signaturesNamed in the posting
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed device
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
- TGAAustralia TGA(official source, opens in a new tab)Australia's Therapeutic Goods Administration
- EUEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissions
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDA21 CFR Part 801(official source, opens in a new tab)FDA labeling requirements for medical devices
Company hiring pulse
Baxter on Regulatory Jobs
- 49
- Open roles
- 49
- Distinct roles
- 11
- Locations
By discipline
- Quality44 88%
- Regulatory6 12%
By level
- Associate & Specialist23 46%
- Senior & Principal11 22%
- Manager8 16%
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Global Regulatory Affairs Publishing Specialist at Baxter
Open until filled. $72K–$99K a year, employer provided.