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
Strategic planning
Performance Evaluations
Policies and procedures
Staff Management
Improvement initiatives
Budgeting
Negotiation
Coaching and mentoring
Schedule Management
Research and analysis
Growth planning
Leadership
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