Regulatory Affairs Manager

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.  

1. Working at Balt means giving meaning to your work! Pride is a strong part of our identity.  
2. We are a close-knit team, with strong mission, vision and values that guide our day-to-day.  
3. Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.  
4. 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 – Regulatory Affairs Manager (Hybrid)

Description:

The Regulatory Affairs Project Manager is responsible for the coordination and preparation of regulatory submissions for new and modified medical devices, license renewals, and annual registrations.  Serves as the Regulatory representative on specific multi-discipline teams, may be responsible for organizing and leading meetings and acts independently to identify and resolve problems. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of projects. Interacts directly with FDA/Notified Body 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.

Provides input to Standard Operating Procedure documents to ensure accuracy and compliance, as appropriate.

Assists with audits and inspections, as needed

Performs other duties and responsibilities as assigned

 

Qualifications and Requirements

 

Skills:

Minimum BA/BS degree or higher in a scientific or technical discipline or relevant field of study.

Five (5) to eight (8) years of professional regulatory experience.

Documented experience in preparation of US and EU submissions

Experience interfacing with relevant regulatory authorities through all stages of device life cycle.

 

Pre-requisites / Job Experience:

Experience in Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), and Pre-Market Approval (PMA) applications

Demonstrate strong project management, 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

Demonstrated MS Office and Adobe Acrobat software skills

Physical Requirements:

Extended periods of sitting or speaking.

Light lifting.

30% domestic and international travel to company sites

Heavy computer use.

Must adhere to the company’s safety practices by performing work safely and in accordance with established standards.

 

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 

 

Please be aware of a current job offer scam perpetrated through the use of the internet. The scammers frequently misappropriate and use a company’s log and photos to give the appearance of legitimacy. The scam preys upon those seeking employment and uses false and fraudulent offers of employment with employers, such as Balt Inc to steal from the victims. Balt believes that one of the best ways to put a stop to this scam is to make sure you are aware of it. Balt’s job recruitment process involves live communication: in person, telephone, and/or video interviews in most cases.

 

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Pay Range$160,000—$180,000 USD