ASSOCIATE MANAGER - REGULATORY AFFAIRS

# LifeStyles is currently looking for new talents #”Job DescriptionGlobal Position: Associate Manager – Regulatory Affairs Position Reports to: Director – Regulatory Affairs & Quality AssuranceGeography: EMEADepartment: Global Regulatory Affairs and Quality AssuranceLocation: Madrid, SpainGENERAL SUMMARY OF POSITIONReporting to the Director of Regulatory Affairs and Quality Assurance, the Associate Manager - RA EMEA participates in ensuring the compliance of products placed on the EMEA market by LifeStyles Healthcare or any subsidiaries (importing entities) with all relevant medical device or product related regulations (i.e. Cosmetics, Battery Directive, General Safety Directive/Regulation) and Standards, including packaging, post market activities (including complaint handling), records, documentation and marketing material.The Associate Manager of RA – EMEA will be actively participating in supporting the business entities with Medical Devices and Cosmetic registrations for the EMEA (Europe, Middle East and Africa) region.This position will participate in the compilation and maintenance of medical device Technical Files and associated RA documentation, working closely with the R&D, Operations and Plant RAQA teams.The position will work closely with our Distributors across the EMEA region to support the collection of PMS data. Across these listed different activities, the position will participate in giving best in class regulatory advice to the business on scope of applicable regulations and their potential impact on packaging, artwork and marketing copies.Additionally, the new joiner will work in a QMS controlled environment, and maintain the harmonization of QMS between importing entities and liaise with Legal Manufacturer QMS. The position will also support the auditing activities at the EU entities and subcontractors.The position will work closely with our manufacturing facilities in Thailand, India and Spain, as well as our Logistic and Warehousing partners to ensure compliance to the European (Medical Device) Regulations and ensure products are properly notified or registered before they are placed on the market.Responsibilities & Specific Accountabilities Supports RA team in compilation and renewal of registration dossiers for the EMEA region.Supports RA team in creation and update of Technical Documentation (CE marked products, Cosmetics).Supports RA team in preparing regulatory notices to the business on scope of applicable regulations and their respective changes.Supports RA team in reviewing/approving packaging, artwork and marketing copy.As they arise, resolve specific administrative and process issues pertaining to regulatory affairs in relevant markets.Support RA team in addressing Notified Body and relevant Competent Authorities requests.Conduct quality regulatory training as appropriate for new and existing employees as requested.Assist in maintenance of importers’ QMS according to MDR 2017/745.Answer Quality and Regulatory enquires from European Competent Authorities.Participate as an Auditor in the Global Supplier and Internal Audit team.Perform other duties as assigned by the Directors Global Quality and Regulatory Affairs.KEY POSITION REQUIREMENTSEducationBachelor of Science in Regulatory, Scientific or Technical Discipline or equivalent combination of training and experience.Job ExperienceMinimum 3 years in Regulatory Affairs or related discipline in medical devices, Cosmetics.Demonstrated leadership and rapport in working with regulatory bodies.Minimum 2 years in QA of Medical devices under ISO13485.Working knowledge of Sexual Wellness (particularly condoms and Lubricants) products preferred.Knowledge and SkillsWorking knowledge of European Medical Device Regulation, European Cosmetic Product Regulation; General Product Safety Directive/Regulation.Working knowledge of Quality Management Systems for Medical Devices.Desirable Job CompetenciesDisplays good communication skills, verbally and in writing.Computer literate (including Project Management Tools). Flexible.Team player/team builder.Ability to appreciate competing priorities, meet deadlinesAbility to work independentlyLanguagesFluent in EnglishFluent in Spanish,Abilities in FrenchAny other language ability will be appreciated.Additional Requirements (travel, etc.)Availability to Travel in EU, no more than 15-20%.About the CompanyLifeStyles has a history dating back to 1905 when Eric Ansell first started making condoms in Richmond Australia.Today LifeStyles is a Global leader in the sexual wellness sector, comprising a broad range of condoms, personal lubricants, and other related products and other products in over 60 countries.Owning a large portfolio of trademarks, LifeStyles manufactures and commercialises its products either under leading global non-latex condom brands SKYN® under its local heroes such as LifeStyles®, Manix®, Unimil®, and Blowtex® and Control®.Outside of branded products, the Company also supports universities, NGOs, and other organizations as part of a broader effort to promote sexual health and prevent the spread of STDs and STIs. LifeStyles owns and operates manufacturing facilities in Thailand, India and Spain, and it employs over 1,600 teammates globally.LifeStyles Healthcare was created on September 1, 2017, when the consortium of Humanwell Healthcare & CITIC Capital private equity purchased the Sexual Wellness division from Ansell.As of December 1, 2022, Lifestyles is owned by Linden Capital Partners, a Chicago-based private equity firm focused on the healthcare industry.This is an exciting time to join us. We combine century-long history with the opportunity of a new beginning as a stand-alone company - this means a new way of thinking, the opportunity to explore new horizons and the chance to make a mark in an exciting, fresh business.LifeStyles Healthcare is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.We are empowered professionals, and we are committed to creating a team of the world’s “best of the best.” Our business foundation is strong, among our values are Integrity and Respect, our people are highly engaged, and we are excited about a new phase in the company history. We have a focus on safety and teamwork - and we want you to join us!All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Discover more about us at: https://www.linkedin.com/company/lifestyles-healthcare/.Curious to know what does every day look like at LifeStyles?Find out by looking at employee testimonials: https://lifestylesglobal.com/careersDue to the high number of applications, we would like to inform you that only selected candidates will be contacted.