Senior Regulatory Affairs Specialist
Provide regulatory support for New Product, Sustaining Engineering, and/or Operations project teams by, identifying the appropriate domestic and international regulatory requirements and developing a regulatory strategy for global product commercialization. Ensuring product registrations are completed in accordance with project schedules. Assessing the domestic and/or international regulatory impact for process improvement and cost savings initiatives. Preparing and submitting documentation to domestic and/or international regulatory authorities, or overseeing this process for more junior level regulatory professionals. Communicating with regulatory agencies, as needed. Researching, preparing, and presenting information for global corporate audiences and senior management. Work independently without direct supervision. Performing other regulatory duties as assigned.
Duties and Responsibilities:
- Represent the Regulatory organization in either cross functional design teams or ancillary support to develop and implement regulatory strategies and carry out associated output responsibilities.
- Prepare or supervise the preparation of global regulatory files/submissions for product registrations as assigned.
- Review and/or approve proposed design changes and ECOs to assess regulatory impact.
- Oversee documentation preparation on various projects, providing guidance and mentoring to junior level RA professionals.
- Assist in reporting and presentation compilation for senior management.
- Interfaces with other ConMed business units/affiliates/distributors as assigned.
- Perform other related duties and special projects as required by management.
- Prepare clinical evaluations.
- Manage product recalls.
Work Experience Requirements:
- Minimum of five to seven years in a regulatory affairs position that includes proof of hands-on submission experience is required.
- Bachelor of Science degree in a science, technical, or related field required or equivalent.
- Knowledge of domestic and international medical device standards and regulations. Knowledge of domestic and international labeling requirements. Ability to execute assignments independently as assigned., Must possess strong organizational skills. Must possess strong written and verbal communication skills. Must possess demonstrated ability to handle multiple priorities simultaneously. Proficient on Microsoft Office products. Multi-Lingual candidatepreferred.