The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements. The Senior Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. Under direction of responsible Regulatory Affairs Management, acts as a decision-maker on regulatory issues, assures that registration/renewal deadlines are met, and supports new product development. Effectively communicates, prepares, and negotiates both internally with cross-functional teams and externally with various regulatory agencies. Properly interprets and applies regulatory requirements.
Essential Job Functions
* Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units
* Outline submission and approval requirements in assigned geographies
* In consultation with Regulatory Affairs Management, develop sound regulatory strategies in alignment with business priorities and update strategy based upon regulatory changes
* Provide regulatory input and technical guidance to product development and operations teams
* Work with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents)
* Review and approve R&D, quality, preclinical and clinical documentation for submission filing
* In collaboration with cross-functional team members, compile, prepare, review and submit on time and high-quality regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan, etc.)
* Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals
* Communicate application progress to internal stakeholders
* Evaluate and maintain current regulatory policies, processes, procedures
* Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements.
* Prepare and maintain annual licenses, registrations/listings for assigned geographies
* Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation
* Provide regulatory input for product recalls and recall communications
* Evaluate import/export requirements
* Identify emerging issues
* Provide other country specific regulatory support
* Other duties as assigned.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.