EMEA International Registration Manager

<p><strong><span data-contrast="auto">About Balt </span></strong><span data-contrast="auto"> </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><span data-contrast="auto">Our purpose is to improve the lives of 150,000 patients in 2026.  </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><strong><span data-contrast="auto">Our story</span></strong><span data-contrast="auto"> </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><span data-contrast="auto">Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices.  Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting. </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><span data-contrast="auto">We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><span data-contrast="auto">We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives. </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><strong><span data-contrast="auto">Why Join Balt? Join a passionate team, dedicated to making a difference. </span></strong><span data-contrast="auto"> </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <ul> <li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Working at Balt means giving meaning to your work! Pride is a strong part of our identity.  </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">We are a close-knit team, with strong mission, vision and values that guide our day-to-day.  </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.  </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="9" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">No matter the country, we take care of you.  </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></li> </ul> <p><span data-contrast="auto">Would you like to be part of our story? Don't hesitate, come and join us! </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><strong><span data-contrast="auto">Description:</span></strong><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><span data-contrast="auto">Driven by strong growth and rapid business expansion, our company is recruiting an EMEA International registration Manager to support regulatory strategy, ensure compliance with applicable regulations, and contribute to the successful development and commercialization of our products.</span><span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":0,"335559740":240}"> </span></p> <p><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><strong><span data-contrast="auto">Job Responsibilities:</span></strong><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Lead and manage activities regarding product registrations in EMEA region except CE marking</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Write, analyze, and edit technical documents to support country-specific regulatory submissions in EMEA and compile submissions in a format consistent with applicable guidance documents.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Maintain regulatory files. Maintain and update regulatory authorizations. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. </span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Collaborate with distributors, UK authorized representative, CH authorized representative and answer their requests</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Assist in preparing responses to regulatory authorities’ questions within assigned timelines.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Stay abreast of regulatory procedures, guidance documents, standards, and changes in regulatory climate. Perform gap assessment.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto">Support external audits, providing regulatory input to minimize potential for findings of non-compliance.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto">Participate in internal audit program</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto">Assess and document regulatory impact of product design changes in jurisdictions where product is licensed </span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1"><span data-contrast="auto">Update regulatory affairs files and trackers (submission files, licenses, and other documents related to EMEA international registrations)</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1"><span data-contrast="auto">Develop and maintain regulatory affairs procedures </span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="13" data-aria-level="1"><span data-contrast="auto">Elaborate KPI and monitor international registrations in EMEA</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="14" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="14" data-aria-level="1"><span data-contrast="auto">Lead and mentor junior staff members</span><span data-ccp-props="{"134233117":false,"134233118":false,"335551550":6,"335551620":6,"335559685":720,"335559737":0,"335559738":0,"335559739":0,"335559991":360}"> </span></li> </ul> <p><span data-ccp-props="{"335551550":6,"335551620":6,"335559685":720,"469777462":[720],"469777927":[0],"469777928":[8]}"> </span></p> <p><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><strong><span data-contrast="auto">Qualification Requirements:</span></strong><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="13" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="none">Minimum of 4-5 years regulatory affairs and or quality assurance experience within a medical device organization </span><span data-ccp-props="{"201341983":0,"335559740":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="13" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="none">Documented training on current medical device standards and regulations is an asset (e.g. MDSAP, EU MDR, ISO 13485, etc.) </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="13" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="none">Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="13" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="none">Excellent written and verbal communication skills with the ability to listen, articulate and advocate </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="13" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="none">Proactive, high performance, result oriented and manage projects with ethical integrity </span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="13" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="none">Technical system skills (e.g. MS office applications, databases, efficient online research)</span><span data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335559737":0,"335559738":0,"335559739":0,"335559740":360}"> </span></li> </ul> <ul> <li data-leveltext="·" data-font="Symbol" data-listid="13" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="none">Master’s degree or country equivalent in Engineering, Science, related scientific discipline, or equivalent. Higher degree will be an advantage. RAPS certification will be an advantage.</span><span data-ccp-props="{"134233117":false,"134233118":false,"335559737":0,"335559738":0,"335559739":0}"> </span></li> </ul> <p><span data-ccp-props="{"134233117":false,"134233118":false,"335559685":0,"335559738":0,"335559739":0}"> </span></p> <p><span data-contrast="auto">More information please go to </span><a href="http://www.baltgroup.com/"><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">www.baltgroup.com</span></span></a><span data-contrast="auto"> </span><span data-ccp-props="{"134233117":false,"134233118":false,"335559685":0,"335559738":0,"335559739":0}"> </span></p>