Regulatory Specialist 2

Remotemid

Legal & ComplianceRegulatory Specialist

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Quick Summary

Key Responsibilities

Provides regulatory support to product development and business teams including preparation of regulatory opinion documents, coordination of labeling activities,

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Legal & ComplianceRegulatory Specialist

This position is a subject matter expert in global medical device and quality system regulations and is responsible for regulatory strategy and planning, authoring and submitting regulatory applications, assessing product design, manufacturing, labeling and quality system changes, authoring change impact assessments, and ensuring product labeling documentation, labels, promotional material, and product claims are accurate and compliant with global regulations. The Specialist will ensure adherence to company policy and procedures and will assist in maintaining quality control processes. This position will help the organization maximize the number of patients served while maintaining a high level of quality and safety through the support of the business functions.

Responsibilities

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→Computer Skills - Skilled with computers, takes advantage of new technology, learns new tools quickly, uses technology to enhance job performance
→Budget - Uses resources efficiently, strives to reduce cost
→Innovation - Creative, offers new ideas, amenable to change, risk taker

→Job Knowledge - Understands facets of job, aware of duties and responsibilities, keeps job knowledge current. Strong understanding of other functional items including product development, design controls and risk management. Strong understanding of medical terminology, regulations, and guidelines related to medical devices and quality systems including FDA’s Quality Management System Regulation (QMSR), MDD 93/42/EEC, MDR 2017/745, and ISO 13485.

→Organization Skills - Information organized and accessible, maintains efficient workspace, manages time well
→Product Expertise - Knows product features, understands marketplace, shares expertise with others
→Professional Development - Seeks to identify one’s self-improvement opportunities at work and takes appropriate action to address
→Project Management - Monitors status of projects, thoroughly deals with project details, holds project owners accountable, delivers clear, accurate depiction of status
→Quality - Strives to eliminate errors, accurate work is a priority, seeks opportunities to improve product/services
→Technical Skills - Maintains understanding of technical processes/equipment, uses technology to increase performance/productivity

Adaptability - Adapts to change, open to new ideas and responsibilities
Communication – Communicates proficiently (written and verbal), delivers presentations, has good listening skills
Conflict Management - Good listener, committed to finding solution to problems, works well with difficult people
Customer Focus - Working cooperatively with internal and external customers in a manner that demonstrates a clear commitment to their needs and success
Decision Making - Able to reach decisions, takes thoughtful approach when considering options, seeks input from others, makes difficult decisions
Dependability - Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
Details – High attention to detail
Ethics - Honest, accountable, maintains confidentiality
Initiative - Takes action, seeks new opportunities, strives to see projects to completion
Interpersonal Skills - Builds strong relationships, is flexible/adaptable, works well with others, solicits feedback
Problem Solving/Critical Thinking - Strives to understands contributing factors, works to resolve complex situations
Productivity - Manages workload, works efficiently, meets goals and objectives
Results Driven - Defines appropriate goals, works toward achieving goals, articulates vision and steps for achievement.
Results/Productivity - Working in a productive, dependable, and efficient manner to produce high quality results in accordance with deadlines and other expectations.
Self-Development - Looks for opportunities to increase knowledge, works to increase responsibility, strives to achieve personal goals
Sense of Urgency - Meets deadlines, establishes appropriate priority, gets the job done in a timely manner, able to work under pressure
Strategic Thought - Works to establish and articulate visions, shows creativity when defining solutions
Teamwork - Demonstrating high levels of teamwork and ability to work cross-functionally