Senior Principal Regulatory Affairs Specialist

How to use this kit

Ground every answer in facts on this page and the original listing. We never invent Glassdoor-style reviews or salaries that are not in our data.

Interview prep

• Walk through a submission you owned end-to-end (strategy, content, agency Q&A).
• Explain how you turn a rule change into policy and training.
• Describe managing multi-market timelines and technical file readiness.

Fit summary

Strong fit if you already lead high-stakes regulatory submissions, agency dialogue, and cross-functional documentation—and want a senior principal scope at Balt Group in Irvine, Orange County.

Day in the role

As a Senior Principal Regulatory Affairs Specialist at Balt Group, a typical day centers on leading complex regulatory work: coordinating and reviewing domestic/international submissions, aligning pre-submission strategy with agencies, drafting agency responses, keeping technical files current for product approval, and translating rule changes into clear policies for the business.

Skills to emphasize

Build depth in submission coordination, agency correspondence, technical file/documentation control, and interpreting regulatory change. No certification resources or costs were provided in the source data for this family.

FAQ from this listing

Is this role remote?

The listing marks remote as no; expect work tied to Irvine, Orange County.

What does the occupation data emphasize?

Submissions, agency communication, technical files, and communicating regulatory changes through policy.

Where can I read the occupation profile?

See the O*NET Regulatory Affairs Specialist summary at onetonline.org.

Occupation tasks (O*NET)

Public-domain labor data — prepare examples for 2–3 of these.

• 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.
• Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
• Coordinate recall or market withdrawal activities as necessary.

O*NET source

Role overview (listing rewrite)

Senior Principal Regulatory Affairs Specialist — Balt Group, Irvine, Orange County 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 To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there. We look forward to hearing from you!

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Questions to ask them

• What does success look like in the first 90 days for this role?
• How is the team structured, and who would I work with most?
• What tools and systems does this role use daily?
• Is the work primarily based in Irvine, Orange County, hybrid, or fully remote?