Global Regulatory Affairs Leader — Hybrid (Med Tech)

Skillcloud; Greenville (PA); Híbrido; USD 120.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Dental insurance

401K with company match

Employee Stock Ownership Plan (ESOP)

Paid time off & holidays

Professional development stipend

Life insurance

HSA and DCA accounts

Hybrid schedule 1–2 days/week

Descripción de la vacante

FHC, Inc is seeking a Regulatory Affairs Manager to lead global regulatory activities and ensure compliance for medical devices across markets. The role supports development, market access, and post-market compliance with a focus on strategy and leadership.

The position involves collaboration with engineering and product teams, oversight of filings, and maintaining registrations while working in a hybrid environment with flexibility for on-site work in Bowdoin, ME or Greenville, PA.

Formación

• Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Quality, or related discipline required; Master’s preferred.

Responsabilidades

• Develop and implement global regulatory strategies for medical devices across development, commercialization, and lifecycle management.
• Provide regulatory leadership throughout design, development, verification, validation, release, and post-market support.
• Advise executives on regulatory risks, opportunities, emerging regulations, and business impact.
• Lead, mentor, and develop Regulatory Affairs personnel.
• Oversee preparation, review, submission, and maintenance of regulatory filings.
• Maintain product registrations in all markets and manage interactions with authorities and notified bodies.

Conocimientos

Regulatory leadership

Regulatory strategy

Global market access

Regulatory submissions

QMS integration

Auditing

Medical devices knowledge

Educación

Bachelor's degree in Engineering/Regulatory/Quality

Master's degree preferred

Herramientas

RAC Certification

CQE Certification

CQA Certification

ISO 13485 Lead Auditor Certification

Descripción del empleo

FHC, Inc is seeking a Regulatory Affairs Manager to lead global regulatory activities and ensure compliance for medical devices across markets. The role supports development, market access, and post-market compliance with a focus on strategy and leadership.

The position involves collaboration with engineering and product teams, oversight of filings, and maintaining registrations while working in a hybrid environment with flexibility for on-site work in Bowdoin, ME or Greenville, PA.