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