Regulatory Affairs Assistant

Regulatory Affairs AssistantLocation: Zuchwill, Switzerland Duration: 12 months Hours: 40 hrs - hybrid working (3 days onsite ,2 days home office)Essential: Regulatory experience covering medical devices, experience gained working in worldwide marketsImagine your next project contributing to product compliance and regulatory submissions for Johnson & Johnson MedTech!Support individuals that execute tasks that are typically routine. Assists in the preparation, delivery, archiving, and tracking of regulatory submissions and similar deliverables to regulatory teams World Wide in support of audits and import/export activities and product registrations.Roles and ResponsibilitiesProvide essential administrative support to ensure product compliance with country and agency regulations, assisting in the full regulatory lifecycle. This will involve:Provides administrative support to ensure product compliance with country regulations.Assists in the collection, validation, and maintenance of files for evaluation by regulatory authorities to provide compliance support for internal and external audits.Collects and stores data and documentation from the relevant agency and other applicable import/export notifications.Ensures prompt and accurate access to regulatory information concerning current, pending, and future submissions, approvals and renewals and requests FSC.Maintains partnerships with other functions to obtain information necessary for submission to regulatory agencies in support of existing and new products, clinical studies, safety requirements, and required life-cycle maintenance.Ensures the updating of regulatory processes, work instructions, training materials, and filing registrations to support Regulatory Affairs based on current regulations.Posts, retrieves, and reports on data from Regulatory Affairs and related databases to ensure prompt and accurate access to company regulatory information.Demonstrates Johnson & Johnson’s Leadership Imperatives and Credo.Provides administrative support to ensure product compliance with agency regulations.Responsible for communicating business related issues or opportunities to next management levelResponsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and proceduresPerforms other duties assigned as neededReports to Regulatory Affairs ManagerWhere applicable may be required to:Acting as office support for the departmentWorks with other department to ensure that a variety of business transactions are completedHost business meetings with other functionsOther tasks and functions as requiredHow to SucceedBring regulatory experience, especially in medical devices, coupled with strong communication and organizational skills. You will also bring:A good first degree in a relevant discipline, or equivalent.Regulatory experience covering medical devices.Knowledge of worldwide regulatory procedures, especially for medical devices.Experience gained working in worldwide markets, and able to demonstrate proven track records of achievementsAble to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.Possess computer competency in Microsoft office software, data collection and general analysis tools.Excellent written, verbal communication and presentation skills.Experience in the preparation and submission of international regulatory filings, including Global Regulations desirable.Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions.Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.Experience desirable of using PLM systems, e.g. Windchill, SAPThis role offers a very competitive hourly rate. This contract will run for 12 monthsYou Are Welcome HereJohnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.About Johnson & Johnson MedTechAt Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.Application ProcessWe are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.Diversity, Equity & InclusionFor more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.