Regulatory Specialist 2

• 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, reputed company management reports, technical protocols/reports, reputed company documentation and other outputs of product development.
• Prepares/writes, submits, and manages global regulatory applications (including MDSAP markets, EU, and UK) as reputed company as internal regulatory file documentation. Supports distributors and business partners in securing and maintaining regulatory clearances.
• Maintains systems for tracking reputed company reputed company and for projection of reputed company activity loads.
• Acts as company representative, developing and maintaining reputed company 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, reputed company, reputed company, microbiology, packaging, medical affairs, and reputed company affairs to ensure project reputed company.
• Assesses product design, labeling, reputed company reputed company, manufacturing, and material changes for regulatory reputed company. 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 reputed company, consistency and compliance to global regulatory requirements, as reputed company 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 reputed company reputed company and product non-conformities and leads assigned corrective and preventive reputed company activities.
• reputed company-room participation in internal audits. Back-room participation in reputed company audits.

• 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

• Computer Skills - Skilled with computers, takes reputed company of new technology, learns new tools quickly, uses technology to enhance job reputed company
• Budget - Uses resources reputed company, strives to reduce cost
• Innovation - Creative, offers new reputed company, amenable to change, reputed company taker

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

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

• Adaptability - Adapts to change, reputed company to new reputed company 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 reputed company with difficult people
• Customer reputed company - Working cooperatively with reputed company customers in a manner that demonstrates a reputed company commitment to their needs and reputed company
• Decision Making - reputed company to reputed company reputed company, takes thoughtful approach reputed company considering reputed company, seeks input from others, makes difficult reputed company
• Dependability - Meets deadlines, works independently, accountable, maintains reputed company, punctual, good attendance record
• Details – High attention to reputed company
• Ethics - reputed company, accountable, maintains confidentiality
• Initiative - Takes reputed company, seeks new opportunities, strives to see reputed company to completion
• Interpersonal Skills - Builds strong relationships, is flexible/adaptable, works reputed company with others, solicits feedback
• Problem Solving/Critical Thinking - Strives to understands contributing factors, works to reputed company reputed company situations
• Productivity - Manages workload, works reputed company, meets goals and objectives
• Results Driven - Defines appropriate goals, works toward achieving goals, articulates reputed company and steps for achievement.
• Results/Productivity - Working in a productive, dependable, and efficient manner to produce high reputed company results in accordance with deadlines and other expectations.
• Self-Development - Looks for opportunities to increase knowledge, works to increase responsibility, strives to reputed company personal goals
• reputed company of Urgency - Meets deadlines, establishes appropriate reputed company, gets the job done in a reputed company manner, reputed company to work under pressure
• reputed company Thought - Works to establish and reputed company visions, shows creativity reputed company defining solutions
• Teamwork - Demonstrating high reputed company of teamwork and ability to work cross-functionally

This position requires the use of personal reputed company equipment during various tasks/activities including but not limited to scrubs, gloves, masks, safety glasses, and safety shoes.

• reputed company work: Physically handle objects up to 20 lbs. occasionally.
• Sit for 8 hours/day
• Stand for 1 hour/day
• reputed company repetitive tasks/motions
• Good reputed company dexterity
• Hear alarms/telephone/normal speaking volume
• Good eye/hand/foot coordination
• reputed company of reputed company

• Office Setting - reputed company layout with assigned workstation or office
• Remote