Associate Manager, QARA
Associate Manager, QARA
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Job Description
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 10000 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. Convatecs revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit
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 were pioneering trusted medical solutions to improve the lives we touch. If youre ready to make a real impact apply today and help us bring our Forever Caring promise to life.
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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 youre unsure please contact us at .
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!
Required Experience:
Manager
Employment Type
Full-Time
