Social network you want to login/join with:
Regulatory Compliance Specialist FDA, Alderley Edge
Client:
CurrentBody Location:
Alderley Edge Job Category:
Other EU work permit required:
Yes Job Reference:
b008b6a9d55f Job Views:
9 Posted:
23.01.2025 Expiry Date:
09.03.2025 Job Description:
About Us: We are
CurrentBody , The Beauty Tech Experts. We are the global leaders in beauty tech, bringing the latest and most effective beauty products to customers across the globe. We are pioneers of one of the most talked about beauty products in recent years, our anti-ageing CurrentBody Skin LED mask and we are making luxury beauty devices accessible to millions. With over 20 international ecommerce sites, we are strategic partners of some of the most exciting and innovative beauty companies too. As we continue to disrupt the beauty market with innovations, category expansion and expert service, we are building a team to drive our growth over the coming years from our Headquarters in Cheshire, England. About the Team: Our Regulatory & Compliance Department is at the forefront of ensuring our products meet the highest standards of safety, quality, and compliance across global markets. Working within the Product Team, driving exciting and innovative projects that bring groundbreaking solutions to consumers. This combines regulatory expertise with creative innovation, ensuring we deliver products that are not only cutting-edge but also compliant with all relevant regulations. About the Role: This role involves providing strategic guidance on regulatory pathways for product development and launches, ensuring adherence to U.S. regulatory requirements, including FDA guidelines for medical devices and cosmetic products. The FDA Specialist will play a key role in supporting the appropriate regulatory strategies and submission processes to bring innovative products to the U.S. market successfully. Provide expert guidance on FDA regulatory pathways and the requirements for premarket notifications (510(k)), De Novo applications, or other regulatory submissions, as applicable. Ensure all product development activities align with FDA requirements, including quality system regulations (QSR) and labelling guidelines. Support the preparation of submissions to the FDA, including any pre-submission meetings or follow-ups. Monitor updates to FDA regulations and guidance, proactively incorporating changes into company processes and strategies. Collaborate with R&D, marketing, and quality assurance teams to ensure U.S. FDA regulatory requirements are integrated into product development processes. Provide training and education to internal stakeholders on FDA regulatory requirements and pathways. Prepare and maintain detailed regulatory documentation to support FDA submissions. Maintain records of all regulatory interactions with the FDA, including meeting minutes and correspondence. Candidate Requirements: Strong understanding of FDA regulations for medical devices and cosmetics, including regulatory pathways and classification requirements is essential. Experience with U.S. regulatory submissions, including 510(k) and De Novo applications is essential. Bachelor’s degree in Life Sciences, Law, Regulatory Affairs, Engineering, or a related field. Exceptional organisational and communication skills with the ability to translate regulatory requirements into actionable strategies. Some of our Benefits: Staff Discount EAP Scheme Regular Social Events On-site subsidised gym (Alderley Park HQ) Cycle to Work Scheme What happens next? Our talent acquisition team will be in touch if you’re successful so keep an eye on your emails. We’ll arrange a short call to learn more about you, as well as answer any questions you have. If it feels like we’re a good match, we’ll share your CV with the hiring manager to review. Our interview process is tailored to each role but typically you can expect a two-stage interview process: 1st stage
– An informal 30-minute video call with the hiring team to discuss your skills and relevant experience. This is a great opportunity to find out more about the role and to ask any questions you may have. 2nd Stage
– A one-hour interview where you can expect competency questions. In most cases this is held in person. As an inclusive employer please do let us know if you require any reasonable adjustments. At CurrentBody, we are committed to creating a diverse and inclusive environment, where all our employees have equal access to opportunities. We strongly encourage applications from all backgrounds, which will be considered regardless of race, colour, religion or belief, gender expression, sexual orientation, national origin, pregnancy and maternity, disability, or age.
#J-18808-Ljbffr
Client:
CurrentBody Location:
Alderley Edge Job Category:
Other EU work permit required:
Yes Job Reference:
b008b6a9d55f Job Views:
9 Posted:
23.01.2025 Expiry Date:
09.03.2025 Job Description:
About Us: We are
CurrentBody , The Beauty Tech Experts. We are the global leaders in beauty tech, bringing the latest and most effective beauty products to customers across the globe. We are pioneers of one of the most talked about beauty products in recent years, our anti-ageing CurrentBody Skin LED mask and we are making luxury beauty devices accessible to millions. With over 20 international ecommerce sites, we are strategic partners of some of the most exciting and innovative beauty companies too. As we continue to disrupt the beauty market with innovations, category expansion and expert service, we are building a team to drive our growth over the coming years from our Headquarters in Cheshire, England. About the Team: Our Regulatory & Compliance Department is at the forefront of ensuring our products meet the highest standards of safety, quality, and compliance across global markets. Working within the Product Team, driving exciting and innovative projects that bring groundbreaking solutions to consumers. This combines regulatory expertise with creative innovation, ensuring we deliver products that are not only cutting-edge but also compliant with all relevant regulations. About the Role: This role involves providing strategic guidance on regulatory pathways for product development and launches, ensuring adherence to U.S. regulatory requirements, including FDA guidelines for medical devices and cosmetic products. The FDA Specialist will play a key role in supporting the appropriate regulatory strategies and submission processes to bring innovative products to the U.S. market successfully. Provide expert guidance on FDA regulatory pathways and the requirements for premarket notifications (510(k)), De Novo applications, or other regulatory submissions, as applicable. Ensure all product development activities align with FDA requirements, including quality system regulations (QSR) and labelling guidelines. Support the preparation of submissions to the FDA, including any pre-submission meetings or follow-ups. Monitor updates to FDA regulations and guidance, proactively incorporating changes into company processes and strategies. Collaborate with R&D, marketing, and quality assurance teams to ensure U.S. FDA regulatory requirements are integrated into product development processes. Provide training and education to internal stakeholders on FDA regulatory requirements and pathways. Prepare and maintain detailed regulatory documentation to support FDA submissions. Maintain records of all regulatory interactions with the FDA, including meeting minutes and correspondence. Candidate Requirements: Strong understanding of FDA regulations for medical devices and cosmetics, including regulatory pathways and classification requirements is essential. Experience with U.S. regulatory submissions, including 510(k) and De Novo applications is essential. Bachelor’s degree in Life Sciences, Law, Regulatory Affairs, Engineering, or a related field. Exceptional organisational and communication skills with the ability to translate regulatory requirements into actionable strategies. Some of our Benefits: Staff Discount EAP Scheme Regular Social Events On-site subsidised gym (Alderley Park HQ) Cycle to Work Scheme What happens next? Our talent acquisition team will be in touch if you’re successful so keep an eye on your emails. We’ll arrange a short call to learn more about you, as well as answer any questions you have. If it feels like we’re a good match, we’ll share your CV with the hiring manager to review. Our interview process is tailored to each role but typically you can expect a two-stage interview process: 1st stage
– An informal 30-minute video call with the hiring team to discuss your skills and relevant experience. This is a great opportunity to find out more about the role and to ask any questions you may have. 2nd Stage
– A one-hour interview where you can expect competency questions. In most cases this is held in person. As an inclusive employer please do let us know if you require any reasonable adjustments. At CurrentBody, we are committed to creating a diverse and inclusive environment, where all our employees have equal access to opportunities. We strongly encourage applications from all backgrounds, which will be considered regardless of race, colour, religion or belief, gender expression, sexual orientation, national origin, pregnancy and maternity, disability, or age.
#J-18808-Ljbffr
