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Position Title :
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:
Provides regulatory support to product development and business teams including preparation of regulatory opinion documents, coordination of labeling activities, and review/approval of design control documentation, risk management reports, technical protocols/reports, clinical documentation and other outputs of product development.
Prepares/writes, submits, and manages global regulatory applications (including MDSAP markets, EU, and UK) as well as internal regulatory file documentation. Supports distributors and business partners in securing and maintaining regulatory clearances.
Maintains systems for tracking current projects and for projection of future activity loads.
Acts as company representative, developing and maintaining positive relationships with global regulatory agencies and business partners through oral and written communications.
Works professionally and cooperatively with cross-functional teams such as research and development, operations, quality, microbiology, packaging, medical affairs, and clinical affairs to ensure project success.
Assesses product design, labeling, quality system, manufacturing, and material changes for regulatory impact. Communicates changes effectively throughout the organization. Authors key portions of company responses to proposed standards, directives, policies and legislation regarding company products and systems.
Develops, processes, and maintains assigned departmental procedures, work instructions, and forms, and facilities training. Reviews and supports creation/updates of labeling procedures.
Supports the design, development, review, and approval of product labels, label items, advertising/promotional materials and product claims to assure accuracy, consistency and compliance to global regulatory requirements, as well as company and customer requirements. This includes verification of labels and advertising/promotional materials, and creation, verification, review, and processing of instructions for use.
Monitors and assesses changes to global regulatory regulations, directives, standards and guidance requirements (regulatory intelligence assessment). Manage project teams for completion of required activities to ensure compliance.
Supports regulatory aspects of the quality system and product non-conformities and leads assigned corrective and preventive action activities.
Front-room participation in internal audits. Back-room participation in external audits.
This is not an exhaustive list of duties or functions and may not necessarily comprise all 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 plus 3 or more years of relevant experience; in lieu of degree, 5 or more years of relevant experience may suffice.
RAC certification(s) a plus
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
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
Behavioral & Basic Skill Competencies
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
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
This position requires the use of personal protective equipment during various tasks/activities including but not limited to scrubs, gloves, masks, safety glasses, and safety shoes.
Activity Requirements and Percentage of Time
NOT AT ALL (0%)
OCCASIONAL (1-33%)
FREQUENT (34-66%)
CONSTANT (67-100%)
Climbing
X
Bending
X
Kneeling/Crawling with Force
X
Pulling
X
Reaching Above Head
X
Twisting at Waist
X
Lift above Shoulders
X
Lift from Floor Level
X
Working Conditions of a Manufacturing Environment or Potential Hazards Include Exposure To:
NOT AT ALL (0%)
OCCASIONAL (1-33%)
FREQUENT (34-66%)
CONSTANT (67-100%)
Hazardous Chemicals
X
Extreme Conditions (hot or cold)
X
Sharp Objects (Saw Blades or other)
X
Moving Mechanical Parts
X
Unprotected Heights
X
Loud Environment
X
Latex Exposure
X
Blood or Body Fluids
X
Communicable Diseases
X
Physical Requirements:
Light work: Physically handle objects up to 20 lbs. occasionally.
Sit for 8 hours/day Stand for 1 hour/day Perform repetitive tasks/motions Good manual dexterity Hear alarms/telephone/normal speaking volume Good eye/hand/foot coordination Clarity of vision
Work Environment:
Office Setting - Open layout with assigned workstation or office
