Insulet Corporation
Clinical Affairs Specialist (Onsite - Acton, MA)
US - Massachusetts (Acton - Office) · Junior
Sponsorship not specified$76k-$115kDetected 29 days ago
GCPClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesResearchCommunicationCollaborationCritical ThinkingRegulatory Affairs
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odds of building a lasting career here
50Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card filing pattern in this occupation
Context, not a finding about this posting: of this employer's 17 green-card filings in this occupation, 100% were for a worker who already held the job.
Green-card follow-through: 85%
Of 13 labor certifications old enough to have been used, 2 expired without the employer filing the next step. Median time from filing to decision: 497 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.
Files H-1B transfers
5 transfer filings in the last year, covering 5 workers. Median labor-condition decision: 8 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- The Clinical Affairs Specialist will play a critical cross functional‑ role within Insulet's Next Generation Platform (NGP) organization.
- This position is responsible for supporting clinical strategy, evidence generation activities, and product development efforts that bridge Clinical Affairs, Regulatory Affairs, Medical Affairs, and R&D.
- The ideal candidate will bring experience in clinical research within medical devices-preferably diabetes, drug delivery, or wearable technologies-and thrive in a highly collaborative, fast paced‑ environment focused on bringing innovative products to market.
Responsibilities
- Support the development of clinical study strategies for new and innovative product concepts.
- Assist in designing clinical protocols, informed consent forms, risk analyses, and related study documents.
- Contribute to clinical evidence plans that support regulatory submissions, product claims, and post‑market needs.
- Participate in design reviews and cross functional project team meetings to represent‑ clinical considerations (user safety, human factors, clinical risks, evidence requirements).
- Support preparation of clinical sections for regulatory submissions (e.g., IDE, 510(k), PMA, CE filings), including literature summaries, clinical data narratives, and review of technical documentation.
- Support operational execution of feasibility, formative, summative, or early phase‑ clinical studies.
- Maintain accurate and complete clinical study files and support audit readiness‑ across assigned projects.
- With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle.
- Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller.
- Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas.
Requirements
- Bachelor's degree in a scientific, biomedical, or engineering field.
- Strong communication and collaboration skills with the ability to work effectively across diverse technical and clinical functions.
- Experience with diabetes technologies, infusion systems, wearable devices, or human factors studies.
- Master's degree in a relevant scientific or clinical discipline.
- Comfort with ambiguity and innovation-thrives in early-stage, exploratory product development.
- Required
- 1 to 2 years of experience in Clinical Affairs, Clinical Research, or a related role within the medical device, biotech, or pharmaceutical industry.
- Ability to manage multiple priorities in a fast paced‑ innovation environment.
- Preferred
- Previous work in a new product development or innovation-focused setting.
- Experience supporting regulatory submissions for medical devices.
- Key Competencies
- Cross-functional influence-comfortable translating clinical needs to technical teams and vice versa.
- Detail orientation with a strategic mindset-capable of supporting both tactical study execution and long-term evidence planning.
- Strong analytical and critical thinking skills-able to interpret data and articulate clinical impact.
Compensation
- Compensation & Benefits:For U.S.-based positions only, the annual base salary range for this role is $76,400.00 - $114,575.00This position may also be eligible for incentive compensation.We offer a comprehensive benefits package, including:
Company info
- We are looking for highly motivated, performance-driven individuals to be a part of our expanding team.
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