Senior Regulatory Affairs Specialist (Hybrid)

Who we want

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. 

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. 

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 

• Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

What you will do

As the Senior Regulatory Affairs Specialist, you will evaluate the regulatory environment providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance. You will assist in the development of regulatory strategy and update strategy based upon regulatory changes.

• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies

• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions

• Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)

• Evaluates proposed products for regulatory classification and jurisdiction

• Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities

• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization

• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes

• Negotiates with regulatory authorities throughout the product lifecycle

• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation

• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

• Assists other departments in the development of SOPs to ensure regulatory compliance

• Provides regulatory input and technical guidance on global regulatory requirements to product development teams

• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations

• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations

• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions

• Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships

• Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process

• Provides regulatory information and guidance for proposed product claims/labeling

• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims

• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines

• Monitors the progress of the regulatory authority review process through appropriate communications with the agency

• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools

• Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees

What you need

• Bachelor’s Degree required; engineering or science degree is preferred.

• 2+ years of experience in an FDA regulated industry required; preferably within medical devices.

• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

• Medical device regulatory experience preferred.

• General understanding of product development process and design control.

• General understanding of regulations applicable to the conduct of clinical trials.

• Familiarity with FDA, Europe and international medical device regulations.