About Convatec Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com **Position Overview:** Japan QARA (hereafter “QARA”) Associate Manager will support the Japanese business concerning all Japan Pharmaceutical & Medical Device Affairs Law (hereafter “regulatory”) and related matters and ensure success of the Japanese business through provision of regulatory support in terms of product filings, product promotional activities, product life cycle management, risk management and change control, in addition to preclinical, clinical and local market quality management. The incumbent will ensure the Convatec Japan business is fully supported in terms of regulatory base business support. This individual will also serve as a key liaison between Convatec and PMDA / MHLW concerning new product submission reviews and any other regulatory inquiries. Additionally, the QARA Associate Manager will interface with other regional other functional areas (e.g., Marketing & Sales, Supply Chain, etc.) to identify and address regulatory requirements applicable to their activities. **Key Responsibilities:** **_Quality_** + Act as appropriate “Quality Controller” in the Marketing Authorization Holder required organization (“3 Controllers”) structure. + Maintain Quality Management System (QMS). + Review, approve and provide guidance for labeling and marketing of Convatec products to ensure optimal claim strategies are employed and to protect Company and business from regulatory action and risks to business continuation. **_Licenses_** + Educate, train, and advise company professionals to ensure appropriate compliance with regulatory requirements. + Maintain MAH / Manufacturing / Sales Licenses and Foreign Manufacturer Registration Licenses. + Ensure product and business continuity by supporting Supply Chain activities and assisting Operations and the market in any customs holds and prefecture or regional licensing issues. **_Regulatory_** + Prepare, submit and obtain fastest optimal clearance of Japan regulatory submissions. Ensure compliance of regulatory submissions and internal filings with all applicable regulations, guidance documents, and internal policies and procedures. Serve as a primary point of contact for Convatec with PMDA / MHLW regarding regulatory submissions and related matters. + Interpret, apply and communicate, in a timely fashion, current, new and revised Japanese regulatory requirements. Provide input and comment to regulations and standards which may affect Convatec products to ensure continuation and ongoing success of the Convatec Japan business. Support strategies in respect of PMDA / MHLW activity and participate appropriately with local trade association or medical device organizations (or other bodies) working groups, or directly, in influencing PMDA / MHLW guidance and regulation development. + Assess the significance of proposed product changes to comply with PMDA / MHLW requirements and industry standards. **​** **_Safety_** + Act as appropriate “Safety Controller” in the Marketing Authorization Holder required organization (“3 Controllers”) structure. + Review adverse event and malfunction reports to assess reportability to PMDA / MHLW. Assess need for Field Safety Corrective Actions or other Field Actions in Japan, in respect of PMDA / MHLW regulations and guidance concerning recalls **Skills & Experience:** + A minimum of at least 5 years of experience in medical device and/or pharmaceutical Quality and/or Regulatory direct activities is required. + Demonstrated knowledge of regulatory requirements and policies applicable to medical devices, and experience interfacing with the PMDA / MHLW / TMG. + Collaborative skills with an ability to work both reactively and proactively in a timely manner with sense of urgency. + Ability to influence and make recommendations at multiple levels of the company. + Proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook, Teams), Adobe Acrobat and Internet-based regulatory resources. **Ready to join us?** At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life. **\#LI-JG1** **\#LI-Hybrid** **Beware of scams online or from individuals claiming to represent Convatec** A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address. If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at careers@Convatec.com . **Equal opportunities** Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law. **Notice to Agency and Search Firm Representatives** Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. **Already a Convatec employee?** **If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!**