Regulatory Affairs Manager, Medical Devices - Hybrid

Skillcloud; Maine; Hybrid; USD 120.000 - 140.000; Vollzeit

Benefits dieser Stelle

Health insurance

401K with company match

Employee stock ownership plan

PTO & holidays

Professional development fund

Life insurance

HSA and DCA accounts

Hybrid work schedule

Zusammenfassung

FHC, Inc. in New England/Western PA offers a Regulatory Affairs Manager role with hybrid work options. The successful candidate will lead global regulatory activities for medical devices, ensuring compliance across FDA, MDR, ISO 13485 and international markets.

Responsibilities include strategizing regulatory pathways, guiding development teams, and maintaining registrations while collaborating with quality, engineering, and senior leadership.

Qualifikationen

• Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Quality, or related field required. Master’s degree preferred.
• Minimum 7–10 years medical device regulatory affairs experience.
• Minimum 3 years leadership or project leadership experience.
• Experience with FDA submissions, international registrations, and global market access.

Aufgaben

• Develop and implement global regulatory strategies for product development, commercialization and lifecycle management.
• Provide regulatory leadership throughout design, development, verification, validation, and post-market activities.
• Advise executive leadership on regulatory risks, opportunities and industry trends.
• Lead, mentor and develop Regulatory Affairs personnel.
• Oversee preparation, review, submission, and maintenance of regulatory filings.
• Maintain product registrations in all approved markets.

Kenntnisse

Regulatory leadership

FDA submissions

Global market access

QMS ISO 13485

Regulatory compliance

Team leadership

Ausbildung

Bachelor’s degree in Engineering/Regulatory

Master’s degree preferred

Jobbeschreibung

FHC, Inc. in New England/Western PA offers a Regulatory Affairs Manager role with hybrid work options. The successful candidate will lead global regulatory activities for medical devices, ensuring compliance across FDA, MDR, ISO 13485 and international markets.

Responsibilities include strategizing regulatory pathways, guiding development teams, and maintaining registrations while collaborating with quality, engineering, and senior leadership.