Regulatory Affairs Strategist

1 week ago

London, Greater London, United Kingdom Lifelancer Full time

About MCRA

MCRA is a pioneering medical device advisory firm and clinical research organization (CRO) with a global presence. Our team of experts integrates regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance to provide unparalleled expertise for clients worldwide.

We have offices in strategic locations, including Washington, DC, Manchester, CT, New York, NY, Japan, and Europe, serving over 1100 clients globally. Our core focus areas include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices.

The Role: Manager, Regulatory Affairs

This critical team member will support regulatory strategy and submissions for our clientele, ensuring seamless communication with regulatory bodies and clients. The primary responsibilities include writing, reviewing, and managing regulatory submissions, developing overall regulatory strategies, and collaborating with senior staff as needed.

As a remote-based employee in Europe, the ideal candidate should possess expertise in EU MDR and UK MDR, with experience reviewing submissions as part of Notified Body staff or familiarity with the CE Mark/UKCA Mark application process. Experience with PRRC or Legal Representative/Authorized Representative activities is advantageous.

Key Responsibilities:

  • Regulatory Services Development: Develop and execute regulatory services for client companies, including technical documentation, CERs, regulatory strategy, analysis development, clinical evidence review, sufficiency assessment, design review, pre-clinical testing, and business development functions to secure new clients and projects.
  • Team Oversight: Review and oversee technical writing and regulatory submission development by junior team members, ensuring high-quality deliverables that meet client and company standards.
  • Collaboration: Work collaboratively with other departments, including clinical, RHEMA, and quality assurance, to stay current on relevant European regulatory requirements and attend conferences and meetings as needed.

Requirements:

  • Bachelor's degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred.
  • Minimum five years of experience in Regulatory Affairs related to medical devices, drugs, and/or biologics, developing regulatory deliverables and submissions, with work experience including writing and/or reviewing regulatory submissions.
  • An understanding of clinical research and data analysis is required.
  • Possesses US and/or International regulatory experience/fluency with regulations (e.g., FDA, Notified Body, ISO 13485).
  • Domain-specific regulatory expertise in a therapeutic area or other MCRA areas of regulatory and scientific expertise may be advantageous.
  • Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines.
  • Able to lead projects with support from MCRA staff and junior team members, taking initiative and ownership of results.

Salary: $120,000 - $150,000 per year, depending on experience.

Lifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, and IT. To apply for this position, visit our website at Lifelancer.com.

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