Regulatory Specialist 2

About the role

This position is a subject matter expert in global medical device and quality system regulations, 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 ensures adherence to company policy and procedures, assists in maintaining quality control processes, and helps the organization maximize the number of patients served while maintaining a high level of quality and safety.

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 projecting 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 and 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 facilitates 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 ensure accuracy, consistency, and compliance with global regulatory requirements, 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).
• Manages 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.
• Participates in internal audits (front-room) and external audits (back-room).

Requirements

• 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 a degree, 5 or more years of relevant experience may suffice.
• RAC certification(s) a plus.

Skills

Technical Competencies

• Computer Skills: Skilled with computers, learns new tools quickly, uses technology to enhance job performance.
• Budget: Uses resources efficiently, strives to reduce costs.
• Innovation: Creative, offers new ideas, amenable to change, risk-taker.
• Job Knowledge: Understands facets of the job, keeps job knowledge current. Strong understanding of product development, design controls, risk management, 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 self-improvement opportunities and takes appropriate action.
• Project Management: Monitors project status, deals with details, holds project owners accountable, delivers clear and accurate status updates.
• Quality: Strives to eliminate errors, prioritizes accurate work, seeks opportunities to improve products/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 solutions, works well with difficult people.
• Customer Focus: Works cooperatively with internal and external customers, demonstrating a commitment to their needs and success.
• Decision Making: Able to reach decisions, takes a thoughtful approach, 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, flexible/adaptable, works well with others, solicits feedback.
• Problem Solving/Critical Thinking: Strives to understand 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.
• Self-Development: Looks for opportunities to increase knowledge, works to increase responsibility, strives to achieve personal goals.
• Sense of Urgency: Meets deadlines, establishes appropriate priorities, 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: Demonstrates high levels of teamwork and ability to work cross-functionally.

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.

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

• Occasional (1-33%): Bending, kneeling/crawling with force, pulling, reaching above head, twisting at waist, lifting above shoulders, lifting from floor level.

Working Conditions

• Occasional (1-33%) exposure to: Hazardous chemicals, extreme conditions (hot or cold), sharp objects, moving mechanical parts, loud environment.

Work environment includes an office setting with an open layout and assigned workstation or office, as well as potential remote work.