New · posted Nov 12
Medline · Medical Devices
Principal Regulatory Affairs
- Eagan, MN
- On-site
- Full-time
- Senior & Principal
The role
Responsible for developing regulatory strategies for global approvals that introduce new products to market and maintain existing products. The position is responsible for negotiating with regulatory authorities, and inform future product development. This position must function independently to resolve regulatory issues, provide direction on projects of large scale with significant business impact, negotiate with regulatory authorities, and inform ongoing project and product development. The Regulatory Specialist Principal leads work groups as a recognized expert in various and diverse area(s) of regulatory and technical competency.
What you need
Education
- B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related.
Work Experience
- Strong global background (5+ years) of di-verse regulatory experience in the medical device industry, including support of pre- and post-market regulatory activities, independent submissions, participating in regulatory intelligence programs, and development and implementation of regulatory strategies in multiple international markets. Sound background and ability to lead efforts related to technical fields such as risk management and design and development.
- Extensive experience authoring and sub-mitting regulatory submissions including 510(k)s and CE Technical Files. Extensive experience communicating and negotiating with regulatory agencies, including FDA and notified bodies.
Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
The anticipated salary range for this position:
$116,000.00 - $174,000.00 Annual
The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.
We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
What you'll do
- In support of business priorities, determine the requirements for completing and maintaining product submissions and regulatory filings for clearance/approval in assigned market(s), including for national or multi-national launch projects. Identify and pro-vide solutions for factors that could impact the success or viability of new product launch in assigned market(s). Monitor changes in regulations that impact current or future requirements and overall compliance; actively propose and execute necessary changes to impacted procedures, products, or records. Acquire and apply knowledge of harmonized standards where applicable.
- Communicate requirements of regulations to internal or external customers. Recommend regulatory pathways, strategies, solutions, and future actions for specific and diverse scenarios, accounting for business objectives and factors relevant to other departments/functional areas.
- Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements. Assess records against multiple requirements sources, including regulations, guidance documents, and standards utilized in various applicable markets that have been identified as applicable.
- Direct and take action to complete and maintain regulatory filings by leading internal groups, collaborating with external groups, providing direction to obtain sup-porting technical information, and implementing focused solutions for identified changes and challenges. Lead direct communication with critical regulators to respond to non-conformances and questions.
- Lead processes and projects involving the development, review, and substantiation of product labeling and claims where needed for various markets and projects.
- Manage complex projects by providing direction on diverse regulatory pathways, defining timelines for technical deliverables and multifaceted project teams, identifying and correcting process deficiencies, and de-fining future actions and solutions.
- Proactively review, improve, and develop regulatory-driven and technical processes.
- Propose, establish, and maintain department databases, logs, and files necessary for ensuring ongoing compliance.
- Oversee and lead internal and external au-dits and manage post-audit corrective actions.
Pay and benefits
$116,000 – $174,000 a year
Employer providedHealth insurance
Life and disability insurance
401(k) contributions
Paid time off
Continuing education & training
Bonus/incentive eligible
Where you'll work
Eagan, MNOn-siteOpen in Maps (opens in a new tab)
More jobs in Eagan, MNEqual opportunity, accessibility and legal noticesMedline's statements, word for word
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 6% below the US median for Regulatory Strategy roles at this level.
This roleEmployer provided
Senior & Principal roles in the US8 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $116,000 | — | $174,000 |
| All US (middle half) | $150,000 | $155,000 | $171,250 |
This role: Medline's own published range. Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 94 open Regulatory Strategy roles on Regulatory Jobs, with the titles they carry most. Not Medline's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- GMP and compliance5
- Regulatory submissions4
- Documentation and SOPs2
- Lab testing and methods1
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Strategy work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed deviceNamed in the posting
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissions
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devices
- EUEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- FDAFDA eSTAR(official source, opens in a new tab)The electronic submission template for 510(k) and De Novo requests
- ISOISO 14155(official source, opens in a new tab)Good clinical practice for clinical investigations of medical devices
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
- 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)
Company hiring pulse
Medline on Regulatory Jobs
- 61
- Open roles
- 61
- Distinct roles
- 20
- Locations
By discipline
- Quality56 85%
- Regulatory9 14%
- Clinical1 2%
By level
- Associate & Specialist44 67%
- Senior & Principal16 24%
- Manager3 5%
More roles at Medline
- View role
Quality Control Inspector I - 1st Shift M-F
Glens Falls, NYAssociate & SpecialistMedical Devices$38K–$56K
- View role
Quality Control Inspector I
Temecula, CAAssociate & SpecialistMedical Devices$42K–$61K
- View role
QC Inspector II (1st Shift)
Neptune, NJAssociate & SpecialistMedical Devices$48K–$70K
- View role
Senior Quality Engineer - Laboratory
Northfield, ILSenior & PrincipalMedical Devices$101K–$152K
Similar Regulatory Strategy roles elsewhere
- View role
Senior Regulatory Affairs Program Lead (Software/OTTAVA)
Johnson & JohnsonSanta Clara, CA · HybridSenior & PrincipalMedical Devices$112K–$208K
- View role
Regulatory Affairs Technical Lead
IntuitiveSunnyvale, CASenior & PrincipalMedical DevicesSalary not listed
- View role
Staff Regulatory Affairs
DanaherRemote, USSenior & PrincipalMedical Devices$150K
- View role
Principal Regulatory Affairs Specialist
PhilipsOrange, OH +1 more · HybridSenior & PrincipalMedical Devices$122K–$217K
Principal Regulatory Affairs at Medline
Open until filled. $116K–$174K a year, employer provided.