Simrat Gill
Project Manager
Sydney,NSW
Summary
Result-orientated leader in the healthcare industry with over five years of project coordination and project management experience. A fast and eager learner, I am detail oriented and adopt to changing project requirements quickly to meet business goals.
Overview
1
1
Language
1
1
year of post-secondary education
4
4
years of professional experience
Work History
Global Post Market Surveillance Manager
Corin group
02.2020 - Current
- Experience Communication skills:.
- Composed high-standard reports and presentations for clients nationally & internationally for various projects.
- Second author for an executive report written for the Ministry of Health (New Zealand) as part of an evaluation project.
- Delivered some high-end projects on e-mental health for the Ministry of Health in New Zealand.
- Ongoing interaction with clients and other stakeholders at various levels to complete projects to a high standard.
- Regular presentations to senior management for various projects such across all levels of the organisation.
- Ongoing communication with various stakeholders around the organization as well as regulatory bodies globally such as FDA.
- Analytical, research & problem-solving skills:.
- Known for thinking “out of the box” and handling problem resolutions with tact and appropriateness.
- Good research and analytical skills developed through conducting various qualitative and quantitative studies.
- Sound knowledge of analysing data using various tools and turning those datasets into insightful and actionable business information.
- Able to identify efficient ways to address variety of tasks and complete them in a time efficient manner.
- Can do” attitude aimed at discovering problems and comprehend situations that can compound them.
- Adept at interpreting complex regulations and translating them into “doable” tasks.
- Working with investigation, operations, or product teams to process complicated complaints.
- Organizational and time management skills:.
- While completing my thesis, I managed multiple projects at Comvita.
- Through consistent prioritization of daily tasks and accommodating for urgent tasks, I completed my projects and met the strict deadlines.
- Previously, managed the load of a master’s degree alongside part-time job.
- Ongoing management of vigilance reports sent to various regulatory bodies globally in a timely manner.
- Completing Health Hazard Evaluations to assess patient risk within given timeframes.
- Trained and managed new starters efficiently whilst leading various projects such as EU MDR alignment and other day to day tasks.
- Effectively managing portfolio of the company which spans across four different sites globally and at the same time managing a team.
- Leadership, Interpersonal and collaborative skills:.
- Work well with diverse personality types and competent to build professional relationships with internal and external stakeholders to improve business output.
- Through my involvement with voluntary organizations and community groups I have met a wide range of people.
- This experience has helped me develop an open mind and given me the ability to deal with people from different backgrounds and cultures.
- Working across the organization daily and liaising with various teams to process and report all vigilance reportable complaints in a timely manner.
- Working across the globe with different stakeholders and time zones to deliver projects of different scopes.
- Set up a new team within the organisation and managing them quite effectively by applying different leadership strategies.
- Plan & manage project management activities across the organisation to ensure ongoing business improvement.
- Work, Lead and manage of all personnel within the Post Market function for the Corin group of companies including recruitment, onboarding, ongoing performance management, motivating, training and development of staff.
- Plan and manage activities of the Post Market department, through the establishment and management of the Post Market team’s performance against departmental objectives and deliverables.
- Design, develop, implement, and maintain a compliant and effective Post Market Surveillance system, including communication with the Food Drug Administration (FDA), Notified Bodies, and Competent or Regulatory Authorities.
- Drive continuous improvement and lean activities to improve efficiencies in Post Market activities.
- Be the champion for IT projects impacting the Post Market function and/or systems.
- Advise and guides management and other personnel in other departments on the interpretation and application of regulations impacting surveillance activities.
- Foster relationships with site and global Operations, Marketing, Product Development, Regulatory, Clinical, and Quality Assurance.
- Make timely quality decisions including escalating to management whenever appropriate and sharing relevant information with multi-region stakeholders.
- Monitor product performance Post Market and recommend any improvements suggestions.
- Achievements:.
- I led the project for aligning Post Market Surveillance & clinical activities with the European Medical Device Regulations for the company.
- Created a global training program for complaints & feedback handling as part of employee & distributor onboarding.
- I am currently leading a project globally to ensure effective trend analysis of all Post Market data.
- Set up a lean project management system across the company which is now being followed across the organisation.
Senior Quality Systems Engineer
05.2019 - 02.2020
- Loading, analysing, and reviewing Post Market data to determine whether regulatory reporting or further action is required.
- Seeking product Surveillance information as necessary to ensure all relevant information is recorded, assessed, and processed in a timely manner.
- Coordinating with the investigations team to determine if the reported complaint was associated with a malfunction, serious injury or death and whether the complaint documentation is complete and accurate.
- Developing vigilance reports (medical device reporting) and responses to regulatory authorities for adverse events and product malfunctions to ensure regulatory compliance and limit regulatory risk.
- Working with multidisciplinary and cross-functional teams across the business units to ensure the timely completion and closure of reportable complaints.
- Independently conducting Post Market projects such design intents, field actions, and health hazard evaluations.
- Responsible for analysing trending complaints, inquiries and service requests and conferring with product group and CAPA managers.
- Assist with the preparation and updating of product`s Clinical and Risk Management documents.
- Projects:.
- I led the development and implementation of the Product Surveillance Database (generation two) for the company.
- This database is used for entering and processing all Post Market Surveillance data.
- I led the assessment and implementation of the new European Medical Device Regulations (EU MDR) project for the Post Market Surveillance team.
- Various small process improvements projects to make the overall complaints handling system leaner and more efficient.
- Achievements:.
- Created more transparent processes for all field actions correspondence to prevent any loss of evidence.
- Worked with investigation managers to clear backlog of complaints quickly and more efficiently.
- Created new processes for Chinese medical device reporting.
- Trained and supervised new staff on various job specific duties.
- Played instrumental role in company-wide risk assessment efforts, supporting enhancements in business processes and controls.
- Consulted with clients on best practices and served as project manager for all process improvements and regulatory initiatives.
- Delivered subject matter expertise for internal and external customers on compliance best practices and quality control.
- Prepared and presented comprehensive reports to upper management, covering issues and recommendations.
- Created and implemented new procedures for all business units to achieve EU MDR compliance and avoid market disruption in Europe.
Regulatory Affairs Specialist
Fisher & paykel healthcare
11.2016 - 06.2017
- Helped with specific project-based work such as tenders in various countries.
- Independently managed registrations in China, Uruguay, Turkey, India, Portugal and Taiwan.
- Ordered RSFGs from the MedSafe website for registrations in various countries.
- Updating SharePoint database with 510(k) questions for product registration in USA.
- Worked with various teams to conduct GAP analysis and impact assessments to ensure timely registrations and no adverse regulatory consequences.
- Worked closely with team members to complete 510(k) submission for various products across the business by collecting appropriate information and creating various documents.
- Ongoing participation in team meetings to further learn about the business as well as regulatory affairs.
- Updating ECNs for various changes in country Job Instructions documents.
- Impact assessment for product obsolescence in different countries.
- Created regulatory requirements documents to capture medical device registration regulations such as labelling and language requirements in various countries.
- Ongoing communication with regulatory authorities, distributors and regional offices to complete projects and deliver on time.
- Aided in MDSAP Audit of the company by compiling important information and updating documents as well as creating frameworks to improve efficiency and outcomes of the audit.
- Reviewing and streamlining documents for futureproofing.
- Achievements:.
- Delivered all projects and tasks on time.
- Identified gaps in country Job Instruction documents which will allow country registration to flow more efficiently.
- Independently created STED and templates for submissions.
- Created processes around making payments to Health Canada more efficient.
- Created documents to capture Regulatory Requirements worldwide including language and labelling.
- Worked with the team to deliver outstanding outcomes to the wider company and prevent loss of sales and production.
Project Manager
HealthTrx global
auckland
01.2016 - 11.2016
Education
in Project Management -
Project Management Institute
Master of Health Leadership & Management - undefined
University of New South Wales
01.2021 - Current
Master of Bioscience Enterprise (MBioEnt) - undefined
University of Auckland
PGDipBioEnt - undefined
University of Auckland
Bachelor of Science (BSc) - Human Nutrition and Psychology
Massey University
Skills
Project Management
Personal Accomplishments
· Fluent (written and oral) in English, Hindi, and Punjabi.
· Selected as top 10 for Miss Universe (New Zealand) in 2016.
· Won first runner up for Miss Asia Pacific International New Zealand in 2018.
· Won the national title for Miss Multinational New Zealand in 2018.
· Represented New Zealand at the Miss Multinational pageant at an international platform in 2019.
· Established model and has worked with some famous international brands.
· Featured in a Bollywood movie as a lead actress in Sydney (Australia).
Timeline
Master of Health Leadership & Management - undefined
University of New South Wales
01.2021 - Current
Global Post Market Surveillance Manager
Corin group
02.2020 - Current
Senior Quality Systems Engineer
05.2019 - 02.2020
Regulatory Affairs Specialist
Fisher & paykel healthcare
11.2016 - 06.2017
Project Manager
HealthTrx global
01.2016 - 11.2016
Bachelor of Science (BSc) - Human Nutrition and Psychology
Massey University
PGDipBioEnt - undefined
University of Auckland
Master of Bioscience Enterprise (MBioEnt) - undefined
University of Auckland
in Project Management -
Project Management Institute
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