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SRG Engineering
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Borehamwood, Hertfordshire
Senior Staff Regulatory Affairs Specialist
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Salary: £50000 - £65000.00 per annum |
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Overview
Senior Regulatory Affairs Specialist - Permanent - North London Key tasks Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance Assists in the development of regulatory strategy and updates strategy based upon regulatory changes Evaluates proposed products for regulatory classification and jurisdiction Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities Negotiates with regulatory authorities throughout the product lifecycle Provides regulatory input and technical guidance on global regulatory requirements to product development teams Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines Qualifications and skills BS in Engineering, Science, or related degree; or MS in Regulatory Science Demonstrate knowledge and skills in areas such as regulatory pathways; risk-benefit analysis; communication and collaboration internally and externally; submission, registration, obtaining approval, documentation, compliance, post-marketing surveillance/vigilance; and distribution. APPLY TODAY This job was originally posted as www.totaljobs.com/job/89854286