Lead Regulatory Affairs Specialist

2 weeks ago

Rahway, New Jersey, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities and Qualifications:
  • Independently contribute to new product development teams by formulating regulatory strategies and preparing necessary documentation for both domestic and international submissions concerning IVD medical devices, emphasizing instrumentation and software/hardware, alongside experience in assay development.
  • Proven ability to engage with subject matter experts (SMEs) and regulatory bodies effectively.
  • Capacity to clearly communicate regulatory risks, potential challenges, and optimal strategies.
  • Prepare, compile, and submit electronic pre-market and post-market regulatory documents within the designated geographical regions.
  • Assemble IVDR-compliant Technical Documentation for IVD medical devices to facilitate EU CE-Mark approval.
  • Collaborate with business partners to assist in ROW submissions for IVD medical devices across various regions including Asia, EMEA, LATAM, and Canada. Maintain international submission dossiers.
  • Formulate and implement submission strategies for designated projects. Track progress on critical project deliverables and provide regular status updates.
  • Evaluate product labeling, publication materials, literature, and website content for accuracy, consistency, and regulatory adherence.
  • Develop and/or modify regulatory procedures as necessary.
  • Offer regulatory guidance to both existing and new cross-functional product teams.
  • Assess new product design protocols related to verification, validation, and risk management.
  • Mentor junior staff on executing essential regulatory tasks, including submissions.
  • Oversee and ensure the quality of work performed by junior team members on collaborative projects.
  • Assist with on-market regulatory activities as directed by management.
  • Evaluate and communicate new or updated regulations to technical teams within the organization.
  • Bachelor’s degree with 5-8+ years of experience in Regulatory Affairs within the IVD or medical device sectors, or a Master’s degree in biomedical engineering and/or RAC preferred, with a minimum of 3-5 years of direct experience in Regulatory Affairs in the IVD or medical device fields.
  • Strong preference for candidates with software/instrumentation experience.
  • Preferred experience with point-of-care molecular IVD test systems, including knowledge of instrumentation and assays.

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