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Regulatory/Labeling Specialist

3 months ago

Marquette, United States Resolve Surgical Technologies Full time
Job DescriptionJob DescriptionResolve Surgical Technologies is a global, world-class CDMO+ that provides new product design, development, manufacturing, quality, and regulatory services in support of leading medical technology companies. Located near Lake Superior, in beautiful Marquette, Michigan, this "must-see" travel destination is truly an outdoor paradise, teeming with natural beauty year-round. With a community that is as beautiful as its shorelines, Marquette is an up and coming city that welcomes all styles of outdoor enthusiasts.

 

POSITION SUMMARY: 

The Regulatory/Labeling Specialist has a basic understanding of medical device terminology, global medical device and quality system regulations, and is responsible for supporting regulatory submissions, assessing product design, manufacturing, labeling, quality system and material changes, and participating in change impact assessments. This position may also be responsible for planning, developing and executing labeling documentation and product labeling. The Specialist will ensure adherence to company policy and procedures and will assist in maintaining quality control processes throughout Resolve Surgical. This position will help Resolve Surgical maximize the number of patients served while maintaining a high level of quality and safety through the support of the business functions.

RESPONSIBILITIES: 
  • Supports regulatory submission activities including US 510(k), EU Technical File/Documentation, and rest of world.
  • Review, support, and process regulatory standard operating procedures and work instructions in compliance with applicable regulations, directives, guidance, and standards.
  • Maintains systems for tracking current projects.
  • Maintains documentation to support product market authorization approvals, licenses, clearances, registrations and certifications.
  • Supports product design, labeling, quality system, manufacturing, and material changes for regulatory impact.
  • Monitors changes to global regulations, directives, standards and guidance requirements and supports updates to regulatory documentation, submissions, labeling, etc. as required (regulatory intelligence monitoring).
  • Provides backroom support during internal audits.
  • Provides backroom support during audits and inspections by regulatory authorities and certification/accreditation bodies.
  • Develops, edits, reviews, verifies and processes labeling documentation and medical device labeling following company procedures, customer/user requirements, and governing laws/regulations. Labeling documentation and labeling to include product labels, instructions for use (IFUs), patient leaflets, implant cards, advertising and promotional material, etc.
  • Ensures labeling documentation and labeling is professional, readable and compliant with applicable global regulations, directives, standards and guidance requirements.
  • Investigate audit findings related to labeling non-conformities.
  • Review, support, and process labeling standard operating procedures and work instructions in compliance with applicable regulations, directives, guidance, and standards.
  • Supports product design, labeling, quality system, manufacturing, and material changes for labeling impact.
  • This is not an exhaustive list of duties or functions and may not necessarily comprise all of the essential functions.
EDUCATION/EXPERIENCE REQUIRED AND/OR PREFERRED:
  • A minimum of a Bachelor’s degree in a scientific or technical discipline, preferably in regulatory, engineering or biological science
  • In lieu of degree, 2 or more years of relevant experience may suffice
KNOWLEDGE, SKILLS, AND ABILITIES:

Technical Competencies

  • Computer Skills - Skilled with computers, takes advantage of new technology, learns new tools quickly, uses technology to enhance job performance
  • Innovation - Creative, offers new ideas, amenable to change
  • Job Knowledge - Understands facets of job, aware of duties and responsibilities, keeps job knowledge current. Basic understanding of other functional items including product development, design controls and risk management. Basic understanding of regulations and guidelines related to medical devices and quality systems including 21 CFR 820 and 201, 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
  • 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 current understanding of technical processes/equipment, uses technology to increase performance/productivity

Behavioral & Basic Skill Competencies

  • Customer-first attitude - Able to work cooperatively with internal and external customers in a manner that demonstrates a clear commitment to their needs and success
  • Adaptability - Adapts to change, open to new ideas and responsibilities
  • Communication – Excellent written and verbal communication skills, delivers presentations, has good listening skills
  • Conflict Management - Good listener, committed to finding solution to problems, works well with difficult people
  • Decision Making - Able to reach decisions, takes thoughtful approach when considering options, seeks input from others
  • Dependability - Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record
  • Ethics - Honest, accountable, maintains confidentiality
  • Initiative - Takes action, seeks new opportunities, strives to see projects to completion
  • Interpersonal Skills - Builds strong relationships, works well with others, solicits feedback
  • Problem Solving/Critical Thinking - Strives to understands contributing factors, works to resolve complex situations
  • Results Driven - Defines appropriate goals, works toward achieving goals, articulates vision and steps for achievement. Ability to be productive, dependable, and work efficiently to produce high-quality results in accordance with deadlines and other expectations.
  • Sense of Urgency - 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.

Work Environment:

  • Office Setting - Open layout with assigned workstation or office.
  • Onsite, in Marquette, MI
  • No travel required