Senior Regulatory Affairs Specialist

Balt; Irvine (CA); Sur place; USD 125 000 - 130 000; Plein temps

Résumé du poste

Balt Group is seeking a Senior Regulatory Affairs Specialist to coordinate and prepare regulatory submissions for new and modified medical devices, renewals, and annual registrations. You will liaise with FDA, Notified Bodies, and Health Canada, guiding cross-functional teams and applying regulatory expertise to drive project success.

You will develop complex global regulatory strategies, review labeling and documentation, and support audits and inspections as needed, contributing to a

Qualifications

• Experience with HDE, IDE, 510(k), and PMA regulatory submissions.
• Ability to coordinate and execute regulatory activities in a team, under timeline pressure.

Responsabilités

• Develop and implement regulatory strategies for global submissions.
• Represent Regulatory Affairs on project teams and align regulatory plans with business goals.
• Prepare, write, review, and file regulatory submissions for US and international markets.
• Support product maintenance and labeling compliance.

Connaissances

Regulatory strategy

FDA interactions

Regulatory submissions

Cross-functional collaboration

Description du poste

About Balt

Our purpose is to improve the lives of 150,000 patients in 2026.

Our story

Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting.

We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.

We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.

Why Join Balt?

Join a passionate team, dedicated to making a difference.

Working at Balt means giving meaning to your work! Pride is a strong part of our identity. We are a close-knit team, with strong mission, vision and values that guide our day-to-day. Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success. No matter the country, we take care of you.

Would you like to be part of our story? Don't hesitate, come and join us!

About This Opportunity – Senior Regulatory Affairs Specialist

On this role, the Senior Regulatory Affairs Specialist is responsible for the coordination and preparation of regulatory submissions for new and modified medical devices, license renewals, and annual registrations. Serves as a seasoned Regulatory representative on specific multi‑discipline teams and acts independently to identify and resolve problems. Applies regulatory expertise to guide cross‑functional partners and demonstrates strategic thinking and creativity in support of projects. Interacts directly with FDA/Notified Body/Health Canada and indirectly with international regulatory agencies on most projects/products at reviewer‑level.

Job Responsibilities

• Develop and implement complex, global regulatory strategies.
• Represent Regulatory Affairs on project teams and partners with cross‑functional teams to ensure alignment of regulatory strategies and organizational objectives.
• Writes, reviews and files regulatory submissions and documentation for the US and internationally.
• Support product maintenance for currently marketed products as necessary.
• Reviews device labeling for compliance with the applicable US and international regulations.
• Reviews product and manufacturing changes for compliance with applicable regulations.
• Reviews advertising and promotion to ensure compliance with product claims.
• Documents, consolidates, and maintains verbal and written communication with regulatory agencies.
• Makes improvements to department processes and systems, as called upon.
• Assists with audits and inspections, as needed.
• Performs other duties and responsibilities as assigned.

Qualification Requirements

• Experience in Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), Pre‑Market 510k, and Pre‑Market Approval (PMA) applications. Demonstrate practical knowledge of project management, in addition to writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities. Ability to work well in a team environment. Works well under pressure in a dynamic, timeline‑driven environment.
• Work Environment: Working conditions are normal for an office environment.

The above information on this description have been designed to indicate the general nature of work performed by employees within this position. This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible responsibilities. tasks, and duties, and does not limit the assignment of additional duties for this position.

Balt Group is an Equal Employment Opportunity employer.

More information please go to www.baltgroup.com

Pay Range

$125,000—$130,000 USD