Sr. Regulatory Specialist
hace 10 días
Bethlehem
Job Description EXALTA Group brings together three industry pioneers under one banner (Intech, Resolve Surgical, and Tyber Medical), reinforcing a shared objective: advancing the future of MedTech with greater clinical impact and improved patient outcomes. New website: . Our Bethlehem, PA location is part of the Integrated OEM Solutions business unit. Location: Bethlehem, PA, Remote optional, Hybrid preferred (2 days/week in office) POSITION SUMMARY: The Senior Regulatory Specialist 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 Sr. 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. This position is critical in helping EXALTA 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 as appropriate., • 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, and medical 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 quality system and regulatory procedures, work instructions, 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, review, and processing 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., • Provides technical guidance and regulatory training, mentoring and development of other Regulatory Affairs employees and cross-functional teams., • Supports all aspects of the quality system and product non-conformities and leads corrective and preventive action activities., • Front-room participation in internal and external audits., • Front-room participation in inspections by regulatory authorities and certification/accreditation bodies. 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 5 or more years of relevant experience; in lieu of degree, 7 or more years of relevant experience may suffice., • RAC certification(s) is a plus KNOWLEDGE, SKILLS, AND ABILITIES: Technical Competencies • Regulatory Expertise: Deep understanding of medical device regulations and quality systems, including 21 CFR Parts 820 and 201, MDD 93/42/EEC, MDR 2017/745, and ISO 13485. Skilled in applying regulatory requirements to product development, design controls, risk management, labeling, and post-market surveillance., • Technical & Product Knowledge: Strong grasp of medical terminology, technical documentation, and product design principles. Demonstrates the ability to translate technical data into clear regulatory submissions and communications., • Project Management: Plans and manages multiple projects effectively, ensuring timelines, deliverables, and compliance objectives are met. Tracks progress and proactively mitigates risks., • Quality & Compliance Mindset: Champions accuracy, documentation integrity, and continuous improvement in regulatory and quality processes., • Technology Proficiency: Demonstrates advanced computer literacy, efficiently using regulatory systems, databases, and document management tools. Quickly adopts new technologies to improve efficiency. Behavioral & Basic Skill Competencies • Communication: Communicates clearly and persuasively across levels and functions. Writes precise regulatory submissions and delivers concise, professional presentations., • Collaboration & Teamwork: Works effectively in cross-functional teams, fostering cooperation among Quality, R&D, Clinical, and Manufacturing. Shares expertise and supports team success., • Critical Thinking & Problem Solving: Analyzes complex regulatory challenges, evaluates options, and recommends sound, compliant solutions., • Adaptability: Adjusts to changing regulations, priorities, and project demands with flexibility and resilience., • Decision Making: Exercises sound judgment and accountability when making regulatory or business-impacting decisions., • Organization & Attention to Detail: Manages multiple priorities efficiently while maintaining exceptional attention to detail and documentation accuracy., • Initiative & Results Orientation: Takes ownership of goals and delivers results within deadlines. Demonstrates a strong sense of urgency and commitment to high-quality outcomes., • Ethics & Integrity: Acts with honesty, confidentiality, and professionalism. Models ethical behavior in all decisions and communications., • Continuous Learning & Development: Seeks opportunities for professional growth and applies new knowledge to enhance performance and compliance outcomes.