Staff Regulatory Affairs Specialist

Ladders; EUA; Teletrabalho; USD 136 000 - 217 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental, and vision coverage

401(k) and deferred compensation

Paid time off and holidays

Parental leave and adoption assistance

Employee assistance programs

Mental health support

Commuter benefits

Resumo da oferta

Ladders is seeking a Staff Regulatory Affairs Specialist to support medical device and in vitro diagnostic programs in a remote, U.S.-based role. You will guide submissions, assess change impacts, and mitigate regulatory risk across the product lifecycle, partnering with product development, quality, and cross-functional teams.

Strong technical writing skills and the ability to translate evolving requirements into practical regulatory strategies are essential for success in this position.

Qualificações

• B.S. degree in a scientific or technical discipline required.
• 5 years of Regulatory Affairs experience in medical device or IVD companies.
• Proficiency in technical writing and compiling successful submissions.
• Experience maintaining confidentiality with regulatory documentation.
• Strong cross-functional collaboration and teamwork skills.
• Proficiency in Microsoft Word, Excel, and PowerPoint.

Responsabilidades

• Coordinate and prepare premarket applications to the US FDA, including 510(k) submissions.
• Assess the need for 510(k) applications for device modifications.
• Prepare technical files for CE marking submissions to European Notified Bodies.
• Provide regulatory guidance to complex product development teams.
• Identify and communicate risks and mitigation strategies in regulatory approaches.
• Assist with Notification of Change assessments for product lifecycle management.
• Develop regulatory strategies for Change Controls and establish requirements.

Conhecimentos

Regulatory affairs experience

Technical writing

Cross-functional collaboration

Regulatory strategy

Formação académica

B.S. degree in a scientific or technical discipline

Ferramentas

Microsoft Word

Microsoft Excel

PowerPoint

Descrição da oferta de emprego

For our client, we are seeking a Staff Regulatory Affairs Specialist to join the team of a leader in the Healthcare space.

This role will support complex medical device and in vitro diagnostic programs, helping ensure regulatory pathways are clearly defined and effectively executed. You will partner closely with product development, quality, and cross-functional teams to guide submissions, assess change impacts, and mitigate regulatory risk across the product lifecycle. The position calls for strong technical writing, sound judgment, and the ability to translate evolving requirements into practical regulatory strategies.

Location: Remote

Compensation: $135,500 – $216,800 annually

Responsibilities

• Coordinate and prepare premarket applications to the US FDA, including 510(k) submissions
• Assess the need for 510(k) applications for device modifications
• Prepare technical files for CE marking submissions to European Notified Bodies
• Provide regulatory guidance to complex product development teams
• Identify and communicate risks and mitigation strategies in regulatory approaches
• Assist with Notification of Change assessments for product lifecycle management
• Develop regulatory strategies for Change Controls and establish requirements

Qualifications

• B.S. degree in a scientific or technical discipline required, such as engineering, biology, or chemistry
• 5 years of Regulatory Affairs experience in medical device or in vitro diagnostic companies
• Proficiency in technical writing and compiling successful submissions
• Experience maintaining confidentiality with regulatory documentation
• Strong cross-functional collaboration and teamwork skills
• Proficiency in Microsoft Word, Excel, and PowerPoint

Benefits

• Medical, dental, and vision coverage, plus health savings accounts
• 401(k) and deferred compensation programs
• Paid time off and company holidays
• Parental leave and adoption assistance
• Employee assistance programs and commuter benefits
• Mental health support and wellness resources

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.