Manager Regulatory Affairs

Job Description

Description

The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes US regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team. Plans and prepares complex regulatory submission documents primarily for US regulatory filings. Utilizing detailed, in-depth understanding of regulations for device products, leads and participates in global regulatory product teams, interprets regulations, and provides regulatory guidance. Supports management with implementation of departmental strategies and policies.

Duties and Responsibilities:

Represents US Regulatory in project teams. Develops US regulatory filing strategy, with input from supervisor. Provides regulatory strategy and guidance to global product owner/project team in line with commercial objectives.

Works collaboratively with GRL/regulatory/cross functional team to resolve complex project issues.

Has recognized regulatory expertise and knowledge of regulatory requirements with ability to strategically interpret and communicate requirements.

Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness.

Ensures planned device development activities comply with US regulatory guidelines, and, in cases where they do not, provide a critical analysis of the risks and issues.

Plans and prepares complex regulatory documents for US (PMA, IDE, IDE supplements and annual reports, FDA meetings) and potentially OUS submissions, under supervision.

Prepares clear, complete, and accurate documents that are logically constructed and comprehensive in content and on time.

Reviews labeling and packaging components for new products/indication extensions to ensure accuracy and compliance with regulations and aligned with the commercial needs.

Communicates planned/approved changes with operations, commercial, medical affairs, and marketing.

Maintains professional relationships with functional areas outside regulatory.

Develops professional relationships with Health Authorities through supervised process.

Establishes relationships with US colleagues as well as global regulatory team to ensure local RA activities are in line with global business priorities.

Assists in training and mentoring of personnel and performs peer review of documents.

Fosters a dynamic working environment by appropriately challenging processes, inspiring a shared vision, enabling others to act, leading by example, and encouraging intra- and inter-departmental team members to meet and/or exceed expectations.