- Company: Balt Group
- Location: Irvine, California
- Salary: $170,000–$200,000/yr
Balt Group at a glance
Senior Principal Regulatory Affairs Specialist — Balt Group, Irvine, California
About This Position
We are seeking a highly experienced Senior Principal Regulatory Affairs Specialist to join our dynamic team at Balt Group. As a key member of the regulatory affairs department, you will be responsible for ensuring that all medical devices comply with international and local regulations, leading cross-functional teams, and contributing to the strategic direction of new product development.
Your Responsibilities
- Lead the preparation and submission of regulatory documents for medical devices to various global regulatory bodies.
- Collaborate closely with R&D, marketing, and manufacturing teams to ensure compliance throughout the product lifecycle.
- Develop and maintain regulatory strategies for new products, ensuring timely market entry.
- Provide guidance on regulatory requirements and trends to support business objectives.
- Ensure adherence to quality management systems and regulatory standards.
What You Bring
- A minimum of 10 years of experience in the medical device industry, with a focus on regulatory affairs.
- Demonstrated success in leading cross-functional teams and managing complex projects.
- Strong knowledge of international and US FDA regulations related to medical devices.
- Experience in preparing and submitting pre-market notifications (510(k)), PMA applications, and other regulatory submissions.
- Excellent communication and interpersonal skills to work effectively with internal and external stakeholders.
About Balt Group
Balt is a rapidly growing pioneer in the medical device industry. Founded 45 years ago, we have been at the forefront of innovation, collaborating closely with physicians and institutions to develop groundbreaking medical devices that improve patient outcomes. With 13 offices spanning 11 countries, our products are used by healthcare professionals worldwide. Our mission is clear: to enhance the lives of 150,000 patients in 2026.
Next Steps
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Working in Irvine, California
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California is a U.S. state in the Western United States that lies on the Pacific Coast. It borders Oregon to the north, and Nevada and Arizona to the east; it also shares an international border with the Mexican state of Baja California to the south. With over 39 million residents across an area of 163,696 square miles (423,970 km2), it is the largest U.S. state by population and third-largest by
🇺🇸 Relocation safety for US: Exercise Normal Caution — via Warnely, CC BY 4.0
National unemployment rate in US: 4.2% — via World Bank
National job openings rate: 4.4% — via BLS JOLTS
Private-sector wage growth (year over year): 3.1% — via FRED
National quits rate: 2.0% — via FRED (BLS JOLTS)
Weekly initial unemployment claims: 199,000 — via FRED
GDP per capita in US: $90,027 — via World Bank
Consumer price inflation in US: 2.9% (annual) — via World Bank
Real GDP growth in US: 2.2% (annual) — via World Bank
Average hours worked per year in US: 1,800 — via OECD
Unemployment rate in California: 5.2% — via U.S. Bureau of Labor Statistics
Cost of living in California: 10.7% above the national average — via BEA
Minimum wage in California: $16.90/hr — via FRED
Real GDP per capita in California: $86,110 — via FRED
Home prices in California (year over year): +1.8% — via FRED
Median household income in Orange County: $113,702 — via US Census ACS / Data USA
Average commute time in Orange County: 27 min — via US Census ACS / Data USA
Most common commute in Orange County: Drove Alone (68%) — via US Census ACS / Data USA
Households with home internet in Orange County: 95% — via US Census ACS / Data USA
Typical climate: average high 74°F / low 52°F year-round (summers around 81°F, winters around 43°F) — via NOAA 1991-2020 Normals
Walkability: Above average walkable — via EPA National Walkability Index
Typical rent nearby: $2,746/mo · $3,236/mo — via HUD Fair Market Rents
- Elevation 22m (72 ft)
Source: Wikipedia (state)
About this role & career path
Traits that fit this role
- Intellectual Curiosity
- Cautiousness
- Integrity
- Attention to Detail
- Dependability
Source: O*NET Work Styles (Distinctiveness Rank).
Typical preparation needed: Job Zone 4: Considerable Preparation Needed. Most of these occupations require a four-year bachelor's degree, but some do not. — via O*NET
Industry news
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- Navigating China's regulatory landscape for AI applications in the financial industry - JD Supra
Source: O*NET (public-domain bulk data)
Salary & compensation
Workers in Business & Financial Operations occupations earn a national median of $76,859 — via US Census ACS / Data USA
Job details above are provided by the employer/source. The sections on this page are compiled from public data sources with AI assistance.
Accommodations: if you need a workplace accommodation to apply for or perform this job, see ADA.gov or EEOC.gov for guidance on your rights and how to request one.
Listing facts
- Role Senior Principal Regulatory Affairs Specialist
- Employer Balt Group
- Location Irvine, California
- Type Full Time
- Pay (from listing) $170,000–$200,000/yr
- Posted August 6, 2026
- Apply by September 6, 2026
- Country United States
- Overview Full job description on this page (301 words)
Facts above come from this job record on Get A Job.AI — not copied from third-party review sites.
Typical work in Regulatory Affairs Specialist
Independent occupational context from O*NET (U.S. public-domain labor data). This is about the occupation, not a rewrite of this employer's posting.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
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Occupation family: Regulatory Affairs Specialist
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