Senior Regulatory Affairs Lead, Medical Devices (Hybrid)

Fresenius Medical Care; Waltham (MA); Ibrido; USD 109.000 - 183.000; Tempo pieno

Vantaggi offerti da questo lavoro

Comprehensive benefits package

401(k) with company match

Paid time off

Parental leave

Performance-based bonuses

Descrizione del lavoro

CH01 CHE Fresenius Medical Care (Schweiz) AG is seeking a Principal RA Associate Devices to develop regulatory strategies for medical devices. This role involves preparing submissions for FDA and working closely with product development teams to ensure compliance with regulations.

The ideal candidate will have a Bachelor's Degree, minimum of 8 years of experience in regulatory submissions, and a strong understanding of U.S. and international regulations. This position offers a hybrid work model and competitive salary.

Competenze

• Minimum 8 years of related regulatory submission experience.
• Experience with 510(k) submissions and international regulations.
• Demonstrated ability to manage multiple projects effectively.

Mansioni

• Develop regulatory strategies for medical devices.
• Prepare submissions for FDA and regulatory agencies.
• Provide guidance on medical device regulatory requirements.

Conoscenze

Regulatory submission experience

Knowledge of U.S. and international medical device regulations

Attention to detail

Project management skills

Strong verbal and written communication skills

Formazione

Bachelor’s Degree

Advanced Degree preferred

Strumenti

Microsoft Office

Descrizione del lavoro

CH01 CHE Fresenius Medical Care (Schweiz) AG is seeking a Principal RA Associate Devices to develop regulatory strategies for medical devices. This role involves preparing submissions for FDA and working closely with product development teams to ensure compliance with regulations.

The ideal candidate will have a Bachelor's Degree, minimum of 8 years of experience in regulatory submissions, and a strong understanding of U.S. and international regulations. This position offers a hybrid work model and competitive salary.