Manager, Regulatory & Medical Affairs

General Purpose of this Job

The Manager, Regulatory and Medical Affairs is responsible for the overall direction, coordination and implementation of DaVita’s Regulatory and Medical Affairs Program for the Clinics. This will include the collection, management and analysis of quality data and the preparation of quality reports. Play a vital role in ensuring practical knowledge of tools and techniques of Continuous Quality Improvement, including analysis and interpretation of data using computer based programs or similar data collection systems is essential. Must be familiar with CKAPS Guidelines and MSQH accreditation;; will participate and assist in preparation for all clinical audits and surveys. Maintain positively contribute to the health industry and support the organization achieve the best quality patients- centred care.

Supervisory Responsibilities

Yes

Essential Duties And Responsibilities

The following duties and responsibilities generally reflect the expectations of this position but are not intended to be all inclusive.

  1. REGULATORY
    1. Support day to day operational regulatory needs.
    2. Lead/participate in negotiations during regulatory approval process for applications with the local regulatory authorities (eg; CKAPs and MSQH).
    3. Coordinate the preparation of pre and post-approval regulatory documents in accordance with agreed timeframes. With includes license application, renewal and modification process – application and renewal tracking, establishing good rapport with local regulatory authorities.
    4. Anticipates new/changing regulations, recognizes, analyze potential problem situations and coordinates with relevant stakeholders to develop strategies to address change in practices or related to clinic operations requirements.
    5. Manage, create, compile, maintain and update regulatory database tracking system.
    6. Coordinate corporate filings for legal entities and support their licensing and company secretarial requirements.
    7. Provides consulting, advisory and training related to Licensing, Regulatory recommendation, Denovo or expansion plan to Project Team, Biomed and Facility Team, ROMs or others relevant teammates.
  1. ACCREDITATION
    1. Ensure all clinics being accredited by Malaysian Standard Quality in Healthcare (MSQH).
    2. Provide support to Quality Team Lead and ensure proper documentation is submitted to accreditation body as required.
    3. Providing MSQH training and provide support to the FA and Clinical teammates.
    4. Organize and actively engage with nursing quality management / improvement committees that will        work on nursing quality management program and activities.
    5. To maintain close liaison with other department to assure coordination, standardization and continuity of quality improvement program.
    6. Establish and maintain tracking systems for nursing quality activities.
    7. Benchmarks facilities outcomes identify and share best practices.
  2. MEDICAL AFFAIRS
    1. Involve in the entire patients journey, utilizing available tools to gather insights from health professionals and patients to refine and enhance the best outcome.
    2. Act as a link between DaVita Malaysia and local regulatory authorities includes others relevant stakeholders, ensuring the all clinic operations/medical license maintain in compliance with appropriate legislation. This will include valid APC (for VMPs, PICs, MOs, and Nurses), active business license and BOMBA license (eg: fire extinguisher renewal).
    3. Maintain and update the necessary SOPs, work instructions, or policies that meet the requirements of local regulations with respect to licensing and patients safety.
    4. Establish the workflow process for Regulatory Medical Affair.

MINIMUM QUALIFICATIONS

Education, licenses, certifications, and experience required to fulfill the essential duties, including computer skills as required.

  • Bachelor and/or Master Degree in relevant field is preferred but individuals with experience in leading a quality improvement program may be considered.
  • Minimum 4-7 years of progressive experience in Regulatory and Quality Improvement Management  in healthcare facility.
  • Able to implement basic search strategies.
  • Must demonstrate integrity, sound judgment, demonstrated leadership skills, and strong interpersonal skills.
  • Ability to build strong relationships with relevant stakeholders and be part of the team with ability to approach staff about quality issues with tact and diplomacy.
  • Excellent oral and written communication skills needed, strong organizational ability required.
  • Outstanding skills in data collection, analysis, and presentation.
  • Experience in the use of spreadsheets (intermediate/advance knowledge of excel and PowerPoint) for QI-related data management and display.

 ESSENTIAL BEHAVIORS, SKILLS, AND ATTITUDES REQUIRED FOR SUCCESS IN THIS POSITION

  • Commitment to DaVita’s values of Service Excellence, Integrity, Team, Continuous Improvement, Accountability, Fulfilment and Fun
  • Self-motivated and able to function independently as well as within a team
  • Demonstrated commitment to customer service; proactively communicate and respond promptly to teammate needs
  • Demonstrated knowledge of adult learning theory and ability to apply to individual learning styles as well as demonstrated effectiveness in teaching skills
  • Strong written, verbal, and interpersonal communications skills including ability to listen attentively and to communicate information clearly and effectively
    • Demonstrated ability to work well with cross-functional groups.
    • Demonstrated interpersonal, collaborative, and relationship-building skills; ability. to interact positively with teammates at all levels across the company
    • Approachable and open
  • Professional presence and excellent presentation skills
  • Demonstrated time management skills and ability to handle multiple priorities according to clinical standards; high degree of initiative
  • Demonstrated ability to present and document work according to standards required
  • Demonstrated ability to maintain absolute confidentiality concerning patient information
  • Demonstrated empathy, consideration, and respect for patients and teammates
  • Demonstrated ability to maintain absolute confidentiality concerning information accessed

LANGUAGE SKILLS

Fluent in the written and verbal skills necessary to perform successfully the essential functions, duties, and responsibilities of the position

  • Ability to read, speak, and write English and Bahasa Malaysia with clarity of expression sufficient to communicate technical and complex concepts to teammates, patients, and patient family members in clear and easily understandable terms required
  • Ability to understand clinical/medical vocabulary written or spoken in English require
Minimum Qualifications

Education, licenses, certifications, and experience required to fulfill the essential duties, including computer skills as required.

  • Bachelor and/or Master Degree in relevant field is preferred but individuals with experience in leading a quality improvement program may be considered.
  • Minimum 4-7 years of progressive experience in Regulatory and Quality Improvement Management  in healthcare facility.
  • Able to implement basic search strategies.
  • Must demonstrate integrity, sound judgment, demonstrated leadership skills, and strong interpersonal skills.
  • Ability to build strong relationships with relevant stakeholders and be part of the team with ability to approach staff about quality issues with tact and diplomacy.
  • Excellent oral and written communication skills needed, strong organizational ability required.
  • Outstanding skills in data collection, analysis, and presentation.
  • Experience in the use of spreadsheets (intermediate/advance knowledge of excel and PowerPoint) for QI-related data management and display.

To inquire about other opportunities or to apply for a job, please contact us today: careers.malaysia@davita.com

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