Job Title Manager, Japan Regulatory Affairs Strategy, Devices Requisition JR000014318 Manager, Japan Regulatory Affairs Strategy, Devices (Open) Location CC-Japan - JPN511 Additional Locations Job Description Summary • Holds responsibility for medical device(s) and supports the Global Regulatory Lead (GRL)/ in the development & execution of the regulatory strategy • In cooperation with Global Device Regulatory team, leads activities to develop and implement regulatory strategies to secure global medical device licenses and approvals. • Manages the content of global regulatory dossiers. Key internal leader and driver of regulatory policy and strategy for assigned medical devices. • Supports fore-mentioned regulatory activities for pharmaceutical products as needed. • Serves in supporting as Health Authority (HA) liaison with MHLW/PMDA for routine communications in support of filings including complete and timely responses during application review/inspection phases. • Advises internal customers who may contribute to communication on Regulatory issues including non-clinical/Clinical Development, and others such as Commercial and Quality. • Recommends and implements changes to projects based on knowledge and expertise, accurate interpretation of health authority regulations, guidances, as well as corporate policies and management-related considerations • Accountable for ensuring that corporate goals are met within the scope of the project • Participates in departmental and corporate initiatives Minimum Requirements Education/Experience/Skills • Bachelor degree; preferably in a pharmacy, scientific or technical field; advanced scientific-related degree strongly preferred • 5 years Medical devices (Class III or IV) regulatory activities experience. • Excellent verbal and written communication skills as well as strong interpersonal skills and tactful negotiation skills. • Functions independently in negotiation and decision-making for project related issues that have cross-functional impact. • Uses problem solving skills to separate and combine tasks into efficient workflow and effectively/creatively solve problems • Hands on experience with preparation of Medical device applications, STED and Briefing book for PMDA meeting. • Japanese native speaker, and also English capability especially in reading, writing and verbal communication skill Preferred qualification • Drug regulatory activities experience • Medical devices/Drug development experience • On-line regulatory document submission through Gateway Working conditions • Candidate must be willing to travel up to 10% of time. • Overseas travel as needed if qualified for the task. • A hybrid work structure where employees can work remotely or from the office, as needed. #LI-KD1 At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Mallinckrodt and let’s do something dynamic together. Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law. Additional information on Mallinckrodt’s hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)