上海招聘

Position Summary:

The role of Regional Complaints Lead is to promote correct standards of product post-marketing surveillance within the designated region by influencing and managing all safety related activities.This role will work closely with the Manager of Customer Quality to develop and implement safety surveillance strategy and provide strategic leadership to the designated region.The individual will interact with and provide oversight to local operating companies to ensure adherence to ASP QMS and surveillance policies.

Job Description:

Under general direction from Customer Quality Manager and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position will be held responsible:

· To implement and sustain the ASP Medical Device Post Marketing Surveillance (Technovigilance) and its integrated programs and pillars.

· To perform all representative duties aligned with local regulations or laws.

· Contribute to the development of local Technovigilance procedures for the region in alignment with company policies and requirements and in compliance with local legislations.

· To attend and grant interactions with local Health Authorities, including Inspections and audits (e.g. FDA, Health Canada, BmfG, MHRA, Department of Health-Australia, COFEPRIS, INVIMA, ANVISA, etc.).

· To maintain contact with the local health authorities for clarifications, requests, updates, or any other requirement in case they are needed for countries where no technovigilance representative is available.

· To ensure inspection readiness for all territories in scope.

· To manage Customer Complaint Services according to internal and external needs and local procedures.

· Compliance Files Reviews Incoming Complaints and Completes Good-Faith Effort to Collect Additional Information as Required.

· Coordinates and Contributes to Customer Response Letters.

· Maintains Compliance to Applicable Foreign and Domestic Regulations Governing the Management and Processing of Medical Device Related Complaints including Protected Health Information (PHI) and Patient Privacy Laws.

· Independently Completes Reportability Determination for Medical Device Reporting to Comply with Government Reporting Requirements by Local Health Authorities, including Inspections and audits (e.g. FDA, Health Canada, BmfG, MHRA, Department of Health-Australia, COFEPRIS, INVIMA, ANVISA, etc.).

· Coordinates Efforts with leadership when engaging ASP Legal DepartmentRegarding Complaints Litigation

· To provide support in setting up/maintaining Technovigilance and Complaint Management System, including alignment with local legislations within the region's territories.

· To work in conjuction with appropriate teams to handle product recalls, complaints, and field actions investigations as well as adverse events and other technovigilance activites within the region of scope.

· To attend in timely manner CAPA activities in regards to complaints, recalls, and other related non-conformances.

· To support the implementation and maintenance of local processes that describe the creation and management of local procedural documents in line with global and local regulatory requirements

· To support business partners to reach the expected compliance of ASP standards (e.g. safety data exchange agreements, complaint transferring, etc.).

· To manage / prepare Periodic Reports, including Technovigilance Reports and other specific local safety reports required by local health authorities and update information of patients' exposure, trends and sales data in territories under scope.

· To manage / prepare or adapt Risk Management Plans as requirement of local health authorities within the region.

· To support Sales, Access and Quality initiatives and review those directly related to safety topics of medical devices.

· To participate in multifunctional meetings in order to provide early advice to the teams, identifying risks and opportunities with the aim of proposing strategies that rationalize or accelerate product’s safety

· To contribute to the company’s objective to provide effective surveillance and improvement for the products.

Other Duties:

· To participate activately in company’s projects as needed.

· To report in dotted line toMarket Quality Manager in terms of local regulations, of local activitiesperformed directly or through third parties or business partners via DataExchange Agreements.

Qualifications:

Education:

Required Minimum Education or Equivalent

? Bachelor’s degree in an engineering and/or health sciences required.

? Advanced degree preferred (e.g. MS, MBA).

Years of Related Experience:

? Minimum of 5 years of experience in safety surveillance in medical device and/or pharma related industry.

? Worked at least 3 years at regional coordination level in a regional scope.

Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:

(Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)

Must Have.

? Strong experience within a global organization in a safety surveillance leadership role including leading cross-site and multifunctional organizations.

? Demonstrated experience and knowledge of Health Authorities including Inspections and audits.

? Demonstrated knowledge of quality systems and other standards.

? Good knowledge of good vigilance practices (GvP) and good documentation practices (GDP).

? Good experience handling product recalls, complaints, and field actions investigations and reporting to MoH.

? Good knowledge in CAPA activities in regards to complaints, recalls, and other related non-conformances.

? Experience providing strategies and activities for product registrations and product flow.

? Proficient in English language and basic knowledge of other local language(s) applicable.

Nice to have.

? Ability to influence, act as a change agent, build consensus, and manage conflict in challenging situations.

? Good verbal and written communication skills including opening lines of communications with diverse stakeholders.

? High problem solving and analysis skills.

? Demonstrated experience shaping a safety and surveillance philosophy within regulated industry.? Experience with new product introductions.

List of Professional certifications, licenses and affiliations. (These are ONLY preferred).

? Health Science Engineer

? Six Sigma

? Other languages different from English

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