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Job Post Details

Senior RAQA Specialist - job post

Kerr
3.2 out of 5
서울
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상세 직무 내용

Operating Company: Kerr
Location: Seoul,,KR
Date Posted: June 14, 2024
Req Number: R5020061


Job Description:

The Role:

In this role, you will ensure full compliance with any applicable regulatory and quality requirements of all regulatory bodies prior to the import and supply of the medical devices that are under Envista product portfolio in South Korea market. You will also act as Regulatory Business Partner to Commercial Team and support Go to Market (GTM) and Revenue Plan for South Korea.

Scope:

Region: South Korea

Business: Envista product portfolio with identified product lines for South Korea

Key Responsibility

Product Registration/Licensing Management

  • Provide innovative regulatory strategies for new product introductions and product changes and assist in maintaining regulatory compliance in South Korea.

  • Identify gaps that that could affect execution and convert global or regional regulatory strategies into practical local strategies.

  • Plan product registrations including change notification and renewal, develop registration dossiers for submission, and monitor the progress, status, and timeline.

  • Work closely with Global, OpCo and regional APAC RA teams, engage with various departments, and liaise with business partners and dealers to achieve regulatory goals that support business objectives.

  • Obtain the regulatory approval for new registration and variations of medical devices in South Korea by ensuring quality and timely submission to regulatory authorities, thereby enhancing business expansion through faster time-to-market achievement.

  • Ensure that KGMP certificates and product licenses are renewed promptly and keep the registration database up to date.

  • Be proactive in identifying and addressing possible delays in regulatory submission and approval by consistently monitoring progress. Implement temporary or long-term solutions as needed, while maintaining open and prompt communication with your reporting manager and other stakeholders to collaborate on risk mitigation strategies at the earliest opportunity.

  • Ensure compliance by adhering to the QA requirements.

  • Adhere to all applicable local regulations when carrying out the designated duties and obligations as outlined in the local regulations, guidelines, and similar documents.

  • Keep abreast of the regulatory changes and trends and provide assessments of the impact of new and changing regulations on company’s areas of interests to the management. Ensure that RA Teams (both Global and APAC) and stakeholders are promptly briefed about emerging regulatory issues and create strategies to mitigate regulatory risks or leverage potential advantages.

RA/QA Operational Matters

  • Manage post-market surveillance activities such as customer complaints, adverse events, and field safety corrective actions (FSCA) including product recalls. Work closely with Global and APAC RA/QA team to ensure prompt reporting to the relevant Authorities until FSCA closure.

  • Develop and maintain a Quality Management System customized to comply with the specific regulations of South Korea to secure the required Establishment Operational Licensing, ensuring seamless operation of the business.

  • Develop, implement, and maintain the required standard operating procedures (SOP), and provide necessary trainings on the regulatory and quality topics to relevant stakeholders.

  • Manage all relevant regulatory assessments and inspections.

  • Exercise independent discretion in determining the strategic course of action for the business, which has a direct influence on the operational outcomes of the local markets.

  • Review and validate marketing and labeling materials.

  • Oversee the screening and regular evaluation of RA/QA partners through the utilization of the Channel Partner Toolkit (CPTK), ensuring that our RA/QA partners uphold the same integrity standards mandated by Envista.

Build Continuous Awareness within Organization on applicable RA Framework

  • Be analytical and innovative to drive the execution of continuous improvement in RA/QA operational processes to improve the effectiveness and efficiency.

  • Represent strongly local Affiliate Regulatory Affairs’ interest and be an outstanding business partner with Global and APAC RA/QA Teams and regional/local Sales and Marketing teams.

  • Establish and build on relationships with key contacts within the organization to support the country, and ensure the strong relationship with the industry associations, regulatory agencies, and external stakeholders.

  • Lobby and influence the formulation of regulations, anticipate, and shape the external environment to create or leverage opportunities.

  • Participate in ad-hoc projects.

Internal Relationship

  • Direct report to Head of RAQA, APAC, based in Singapore.

  • Peer relationship with RA/QA Teams (Manufacturing facilities, Global & APAC), local/regional sales & marketing team, supply chain team, technical support team and finance team.

External Relationship

  • Government agencies

  • Industry/Trade associations

  • Channel Partners, e.g., distributors, consultants, etc.

  • Legal agencies

Measurement

  • Regulatory: On time submission/approval/renewals, lead time and responsiveness, and deliverables align with GTM and Revenue Plan in the country

  • Quality: Maintenance of Quality Management System with 100% compliance, including on time change management and Post Market Surveillance activities.

  • Level of Envista Business System (EBS) zealotry and implementation

Job Requirements:

Requirement for the Position

  • Bachelor's Degree in a relevant scientific discipline.

  • Minimum 6 years of relevant experience in RA/QA in the medical device industry.

  • Multinational Company experience preferred.

  • Good knowledge of the laws and regulations governing RA/QA.

  • Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.

  • Proficient in English language – both spoken and written communication.

Most Important Competencies Required

  • Proficiency in MS Office, Excel, and Adobe Acrobat.

  • Good negotiation skills & communication skills.

  • Strong analytical & outstanding problem-solving skills

  • Hands-on, detail-oriented, and meticulous.

  • Ability to interact at all levels of the organization.

  • Ability to articulate a clear vision and convey a sense of urgency.

  • Capability and readiness to take charge and collaborate within the organization.

  • Self-motivated, self-organized, and able to work with minimum supervision.

Operating Company:

Kerr

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.

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