Regulatory Specialist 2

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 Qual