Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist is a key individual contributor supporting regulatory strategy and compliance across the product lifecycle.

Regulatory and Quality report to the Compliance Department. This position reports to the Chief Compliance Officer.

Principal Duties & Responsibilities

Participate in internal compliance audits (e.g. FDA, ISO, etc.) and actively participate and represent the company in 3rd party inspections.

Maintain up-to-date knowledge, identify, and monitor applicable standards and guidance documents for relevance, and communicate changes for timely implementation.

Manage, update, and enhance QMS activities and documents to meet compliance needs.

Support the product development team in the evaluation and translation of various complex FDA regulations and ISO standards including, ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, and IEC 62366 into project objectives, deliverables, and activities.

Review regulatory labeling and documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.

Provide regulatory analysis and recommendations to support product classification decision and submission pathways.

Assist with preparation of regulatory filings such as 510(k) and DeNovo submissions and subsequent revisions/supplements and amendments by managing associated deliverables and timelines.

Ensure clinical studies adhere to applicable regulations and guidelines, including FDA and ICH standards.

Assist with developing and implementing pre-clinical test strategy and provide guidance to team members on execution strategy.

Support the preparation and submission of clinical trial site ethics review board applications and maintain communication throughout the study.

Develop, review, and update clinical design control documents including providing advice and guidance to product development team on development of technical summaries, clinical risk assessments, product training, instructions for use, design of validation protocols and reports, usability protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in product development.

Ensure procedural, medical, scientific, and economic factors are considered during cross-functional product development project team meetings.

Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports.

Qualifications (Education, Experience, Skills)

BS in health profession or science preferred

10+ years of Regulatory/Clinical experience and relevant accomplishments

ISO 13485:2016 Lead Auditor Certification preferred

Direct experience within an FDA regulated Class II software medical device organization

Familiarity and comfort with software terminology and test strategy

Understanding of economic endpoints to support Current Procedural Terminology (CPT) codes process and Health Technology Assessment (HTA) assessment for market access preferred.

Demonstrated understanding of advanced technical principles related to regulated environments and harmonized standards

Impeccable attention to detail and organization skills

Strong planning and analytical skills with demonstrated business impact in previous roles

Self-driven with proven ability to simultaneously manage complex projects and timelines while handling the pressure of demanding deadlines

Understands the need for balancing high quality output with a high efficiency level

Excellent written and oral communication skills; technical writing capabilities and ability to convey complex issues in a straightforward manner are a must