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As a member of the Regulatory Affairs team, the Regulator Affairs Specialist will be responsible for developing regulatory strategy and assessing regulatory risks for products (for both registration and change), driving IVD (as well as RUO, Veterinary, and/or Industry) products through government/regulatory approval processes. Capture and communicate worldwide regulatory requirements for product development, global product registrations, and / or life cycle management. Preparation of FDA and EU submission files and communication with Health Authorities to ensure regulatory approval. This position may require support from more senior RA members/RA managers.

Essential Job Duties and Responsibilities

+ Organize, updating, and maintain regulatory documentation in accordance with company policy and procedures.

+ Participate in the preparation of regulatory submissions (US, EU, Global) and additional information or responses as requested by regulatory agencies.

+ Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

+ Perform interpretation of regulatory rules or rule changes and ensure their proper communication through corporate policies and procedures.

+ Perform assessment of change requests (device/labeling), with minimal oversight.

+ Write or update standard operating procedures and work instructions.

+ Begin to advise project teams on subjects such as premarket requirements, registration requirements, compliance issues, and export and labeling requirements, with some oversight from more senior regulatory specialist / manager.

+ May begin to mentor or train more junior regulatory personnel/trainee, where applicable.

+ Can be given tasks with relatively little oversight and trusted to complete them appropriately.

+ Can lead meetings and guide discussions regarding regulatory topics.

+ Can be assigned projects to lead on their own with some guidance from senior regulatory employees/managers.

+ Ensures accurate population of databases for tracking global product registrations.

Minimum Requirements:

+ Bachelor’s degree. Science background is preferred. 3+ years in regulatory affairs, medical device/IVD industry required

+ or MS degree with 1 year in regulatory affairs, medical device/IVD industry required

+ 1+ year experience with FDA

Knowledge, special skills and/or abilities:

+ Very strong written and oral communications skills

+ US: Fluent verbal and written communication in English

+ Ability to work well within a global team environment.

+ Ability to analyze and understand technical and scientific documents