Jobs / United States / Philips North America LLC
Regulatory Affairs Specialist 3
Philips North America LLC · 🇺🇸 Alajuela
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 25 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest May 2026) — the step every H-1B hire needs first. USCIS also records 14 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Philips North America LLC
The US Department of Labor certified 25 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest May 2026) — the step every H-1B hire needs first. USCIS also records 14 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Philips North America LLC →
About the role
Job Title Regulatory Affairs Specialist 3 Job Description Regulatory Affairs Specialist 3 Responsible for driving regulatory strategy, ensuring product compliance, and supporting market access for medical devices across global and high surveillance markets. Your role: • Drive and implement global regulatory strategies and roadmaps, ensuring alignment with product marketing strategies, New Product Introductions (NPI), and requirements in high surveillance countries. • Lead regulatory planning and execution across the product lifecycle, including submissions, product registrations (e.g., CE Marking), labeling reviews, and compliance protocols, ensuring adherence to international standards and local regulations. • Monitor and manage regulatory risks and product safety by conducting risk assessments, handling compliance issues in systems such as TrackWise, and driving corrective and preventive actions in collaboration with cross‑functional teams. • Collaborate with global and regional stakeholders (Regulatory Affairs, Quality, R&D, Marketing) to support regulatory filings, certification processes, UDI/GTIN activities, and continuous improvement of regulatory processes and systems. You're the right fit if: • You have +2 years of experience in Regulatory Affairs, Quality Compliance, or Product Development within the medical devices industry with a Bachelor’s degree, or no prior experience required with a master's degree, preferably knowledgeable in Quality Compliance or similar fields. • Knowledge of regulatory requirements, product registrations, risk management, regulatory submissions, labeling compliance, stakeholder management, and continuous improvement methodologies. • Experience with high surveillance markets, familiarity with regulatory systems (e.g., TrackWise), strong analytical and problem‑solving skills, and RAPS RAC certification is a plus. • Bachelor’s or Master’s degree in Biomedical Engineering, Health Sciences, Pharmaceutical, Business Administration, Law, or a related field. • Ability to fluidly communicate in English is required. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.t. This is an in office role with Administrative shift. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. • Learn more about our business . • Discover our rich and exciting history . • Learn more about our purpose . If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here .