Description

Position Summary

Provides regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensuring that it is effectively presented for the registration of products. May serve as a lead regulatory representative to an assigned product or project team.

Essential Duties & Responsibilities

Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations.

Plans and organizes registration packages. Prepares registration packages in line with local regulatory requirements and guidelines.

With oversight, serves as a liaison with regulatory agencies pertaining to assigned products/teams.

Assists in the preparation of agency meeting packages and strategies for agency meetings.

Evaluates manufacturing and labeling changes, and promotional materials for regulatory impact with guidance. Accurately describes these changes for ease of regulatory agency review.

Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions.

Work on special assignments as they arise

Knowledge, Skills & Qualifications

Three to five years of experience in Regulatory Affairs, Research, Development or related area.

Software experience (preferred)

510(k) / Q-sub / Response experience (preferred)

MDR Technical Documentation experience (preferred)

Able to follow scientific arguments.

Good interpersonal skills.

Good oral and written communications skills. Developing negotiating skills.

Developing understanding of business needs.

Exceptional interpersonal skills; professional demeanor and attitude High level of attention to detail

Excellent verbal and written communication skills

Ability to prioritize key business objectives and respond quickly to changing priorities Ability to work independently with minimal daily instruction

Able to multitask and work in a fast-paced environment




Education and Experience

Bachelor’s degree from an accredited college or university is required, Masters preferred Minimum 3 years of experience

Travel Requirements

Typically requires travel less than 5% of the time

Physical Requirements and Work Environment

This is largely a sedentary role.

This job operates in a professional office environment and routinely uses standard office equipment.

Education: Bachelors Degree