Regulatory Affairs Manager

Regulatory Affairs Manager

This position provides strategic regulatory leadership for the Invasive Cardiology programs. This includes leading major regulatory projects, programs and regulatory submissions, working closely with a cross-functional team and global regulatory bodies. The Regulatory Affairs Manager will be involved with regulatory activities such as global premarket submissions and registrations, device classifications and determinations, project management, business communication and strategy, risk management, post-market reporting, regulatory intelligence, regulatory requirements flow-down, advertising and promotion review, product labeling compliance, etc.

Roles and Responsibilities

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally

Develops global regulatory strategies, including execution of the regulatory product registrations to support global new product introduction launches. Works closely with cross-functional teams like engineering and product management to drive solutions.

Assesses changes in existing products and determines the need for new / revised licenses or registrations.

Reviews and approves advertising and promotional material to ensure consistency with approved claims and regulatory requirements.

Leads regulatory inspection support, as well as support for regulatory inquiries from authorities related to adverse events or recalls.

Developing specialized depth and/or breadth of expertise in own job discipline or field. Serves as best practice/quality resource. Has awareness of latest functional developments in own area. Contributes towards strategy and policy development, and ensures delivery within area of responsibility.

Skilled influencer, able to communicate complex messages to others. Acts as a resource for colleagues with less experience. May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field.

Uses judgment to make decisions or solve moderately complex tasks or problems that impact the function. Takes new perspective on existing solutions. Uses technical experience and expertise for data analysis to support recommendations. Uses multiple internal and limited external sources outside of own function to arrive at decisions.

Required Qualifications

Bachelor's Degree in a Scientific or Engineering discipline (OR a minimum of 12 years work experience.)

A minimum of 8 years Regulatory Affairs / Quality Assurance experience

A minimum of 8 years experience in the medical device or pharmaceutical industry

Desired Characteristics

Strong oral and written communication skills.

Strong interpersonal and leadership skills.

Demonstrated ability to analyze and resolve problems.

Demonstrated ability to lead programs / projects.

Ability to document, plan, market, and execute programs.

Established project management skills.

Advanced degree in scientific, technology or regulatory affairs disciplines

Regulatory Affairs Certification (RAPS)