Regulatory Support Specialist Job at Uber (Sydney)

Regulatory Specialist

At 2San, we are at the forefront of innovation in the global healthcare industry...

Location

United States , Norwood

Salary:

80000.00 USD / Year

2San

Expiration Date

Until further notice

Requirements

Proven regulatory affairs experience within the healthcare sector, with a focus on Class 2 and Class 3 Self-Test IVDs
Deep understanding of regulatory requirements and processes for the US market, including 510(k) management, FDA submissions, and compliance management
Experience with developing, implementing, and managing Quality Management Systems (QMS) in accordance with US and international standards, including familiarity with ISO 13485
Ability to develop and implement regulatory strategies that align with company objectives and product lifecycle
Strong analytical skills for assessing regulatory compliance, interpreting guidelines, and resolving complex issues
Excellent written and verbal communication skills for effective liaising with regulatory bodies, internal teams, and external partners
Proactive in identifying potential regulatory obstacles and developing effective solutions
Meticulous attention to detail with the capability to manage multiple projects and priorities simultaneously
Bachelor’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering) required
advanced degrees or certifications in regulatory affairs or quality assurance preferred

Job Responsibility

Monitoring and management of new and existing 510(k) entries to ensure all product listings are current and compliant with regulatory requirements
Preparing and submitting FDA applications for new product approvals and amendments for existing products, ensuring all submissions are accurate and meet regulatory standards
Maintaining the regulatory tracker to ensure all information is current and in-line with local requirements
Maintaining regular contact with manufacturers for products supplier in US. Ensuring that their conformity assessment is not due to lapse and ensuring that a plan is in place for updated certification. (IVDD to IVDR)
Regularly reviewing and updating the Quality Management System (QMS) to ensure it aligns with both US and international standards, including ISO 13485, and addressing any gaps or non-compliances
Overseeing Complaints Management and Post-Market Surveillance Activities, including the collection, analysis, and reporting of customer feedback and adverse events to regulatory bodies as required. Implementing corrective actions and ensuring continuous product quality and safety monitoring in compliance with regulatory requirements
Collaborating with product development teams to provide regulatory guidance and support from concept through to commercialization, ensuring regulatory considerations are integrated into product lifecycle management
Navigating regulatory pathways to secure product approval and market entry, including strategizing for efficient and compliant product launches
Applying strong analytical skills to assess regulatory compliance, interpret complex regulatory guidelines, and undertake risk assessments for regulatory strategies and submissions
Proactively identifying potential regulatory challenges and obstacles and working collaboratively with cross-functional teams to develop and implement effective solutions

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...

Location

Italy , Bologna

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
Relevant certifications in Regulatory Affairs are considered a plus
Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong attention to detail, time management and organizational skills
Willingness to learn and ability to work effectively in a team-based environment
Strong communication and interpersonal skills
Proficiency in Microsoft Office Suite and familiarity with document management systems
Fluent in English, both written and spoken

Job Responsibility

Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
Support regulatory strategies by providing impact assessments
Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
Assist colleagues with administrative tasks
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Regulatory Reporting Specialist

The candidate will be in charge of preparing and submitting regulatory reports t...

Location

Italy , Rome

Salary:

Not provided

Aegis FSI

Expiration Date

Until further notice

Requirements

Degree-qualified with a strong track record (3+ years) in regulatory reporting in the financial services industry
In-depth knowledge and proven experience with European banking prudential regulations
Fluent English language skills, both written and spoken
Ability to perform accurately and efficiently under pressure and meet tight deadlines
Strong analytical skills with the ability to accurately identify, evaluate, and manage regulatory requirements

Job Responsibility

Lead the analysis and interpretation of prudential regulatory requirements from the Bank of Italy and EU, ensuring compliance and alignment with internal policies
Develop and implement strategic reporting solutions, while supporting group-level regulatory reporting in close collaboration with the Shared Services Regulatory Reporting Team
Evaluate the regulatory implications of new business initiatives and evolving prudential regulations (e.g. Basel 3+)
Contribute to effective regulatory change management by promoting cross-functional understanding and supporting the design and coordination of consistent implementation plans
Drive the financial planning and execution of high-impact strategic and regulatory projects
Contribute to the preparation and delivery of ICAAP documentation and Pillar 3 reports in line with regulatory expectations
Act as the primary point of contact for the external regulatory service provider, ensuring effective collaboration and service delivery

Regulatory Reporting Specialist

Solaris is a tech company with a full German banking license. Our Banking-as-a-S...

Location

Germany , Berlin

Salary:

Not provided

Solarisbank

Expiration Date

Until further notice

Requirements

5+ years of professional experience in the regulatory reporting environment of a bank or financial institution in Germany
Hands-on experience in preparing and submitting regulatory reports
Knowledge in CoRep and/or FinRep is highly desirable
Practical experience working with regulatory reporting software
Familiarity with OneSumX (Wolters Kluwer) or Regnology would be a significant advantage
Solid understanding of accounting principles is a strong plus
Skilled at independently analyzing new requirements and translating them into concrete implementation projects
A proactive individual who sees challenges as opportunities and enjoys improving processes
Excellent communication skills and thrive both when working independently and as part of a collaborative team
Fluent in both German and English (German is a mandatory requirement for this role)

Job Responsibility

Core Responsibility: Regulatory Reporting: You will take charge of preparing and submitting of regulatory and statistical reports under the CRR and KWG
Regulatory Implementation: You will continuously monitor regulatory developments, analyze their impact on our organization, and take responsibility for the implementation of new requirements
Technical Process Improvement: You will drive the enhancement and automation of our reporting systems by defining and testing data requirements and optimizing existing workflows
Collaboration and Quality Assurance: You will work in close partnership with the Finance department and our Financial Data Department to ensure the consistency and quality of the underlying data
Business Growth Support: You will provide regulatory guidance for the onboarding of new partners and products, ensuring all new activities are compliant from the start
Stakeholder Communication: You will be a point of contact for auditors and supervisors, fostering a professional and transparent relationship

What we offer

Home office budget
Learning & development budget of €1000 per year and a transparent growth framework to support your career goals
Competitive salary and a variable remuneration program
Monthly meal allowance
Deutschland ticket subsidy
28 vacation days, increasing by 2 days after 2 years and 3 days after 3 years with Solaris
Opportunity to work abroad for up to 12 weeks per year

Trading Desk Support Senior Specialist

Trading Desk Support Senior Specialist is a critical subject matter expert posit...

Location

Poland , Warsaw

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Min. 6 years of relevant experience
Proficient English knowledge
High stress resistance
In-depth knowledge of various capital market products (Equities, Derivatives, Fixed Income, FX, etc.) and their operational lifecycles
Consistently demonstrates clear and concise written and verbal communication skills
Strong understanding of trade lifecycle processes, including trade capture, confirmation, settlement, and reconciliation
Strong communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders

Job Responsibility

Governance of Middle Office activities conducted by 3rd party vendor
Monitors trade flows and troubleshoot any trade discrepancies or breaks, liaising with brokers, custodians, and counterparties as necessary
Maintain trade support processes and procedures to enhance operational efficiency and mitigate risk
Provide training and support to junior team members and assist in their professional development
Analyze trade data and generates reports to monitor trade activity, identify trends, and support decision-making processes
Stay updated on industry trends, market developments, and regulatory changes impacting trade operations
Provide support for trade execution, including trade confirmation, settlement, and reconciliation
Monitor trade lifecycle events and ensure trades are processed accurately and in a timely manner
Participate in the testing and implementation of trading systems and upgrades or enhancements
Investigate and resolve trade discrepancies or breaks with brokers, custodians, and counterparties

What we offer

Paid Parental Leave Program (maternity and paternity leave)
A supportive workplace for professionals returning to the office from childcare leave
Award-winning pension plan
Multisport
Holiday allowance
Private Medical Care Program
Group Life Insurance
Consideration for annual discretionary bonus
Employee Assistance Program
Access to a wide variety of learning and development programs, online course libraries and upskilling platforms, such as Udemy and Degreed

Fulltime

Junior Regulatory Affairs Specialist

Junior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices.

Location

Italy , Rome

Salary:

Not provided

Cosmo Intelligent Medical Devices

Expiration Date

Until further notice

Requirements

Bachelor’s degree in engineering, science or related scientific discipline, or equivalent
Minimum of 2 years of experience in regulatory affairs roles within the medical devices or healthcare industry
English proficiency at professional level
Professional knowledge of Reg. (EU) 2017/745 and Title 21 CFR parts 800-898 and technical standards ISO 13485, ISO 14971
Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy
Strong analytical skills with a detail-oriented approach
Ability to work independently and collaboratively across multifunctional teams
Highly dynamic and adaptable to a fast-moving and innovative environment

Job Responsibility

Assess, prepare, and manage technical documentation to support certification and submission processes in the European Union and U.S.A
Prepare and manage technical dossiers for submission in other countries according to local regulations and guidance documents
Cooperate with other departments to the creation and update of technical documentation needed according to country requirements
Assist external stakeholders in the regulatory process per country requirements
Maintain and update certifications, registrations, and renewals as required by country regulations and assess regulatory impact of medical device changes with respect to country requirements
Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect
Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape
Assist in internal and external audits and provide regulatory input to optimize company compliance and minimize the possibility of non-compliance findings
Promote the culture of compliance by proactively interacting with all departments and by provision of trainings
Cooperate to the development of new activities, adapt to new challenges and opportunities, and take on new duties stemming from the development path of company activities

Loan Servicing Support Specialist

URGENT contract opportunity for a highly detail-oriented Loan Servicing Support ...

Location

United States , Boise

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Proven experience in loan administration, mortgage servicing, or related fields
Strong knowledge of escrow management, including tax and insurance disbursements
Proficiency in analyzing data and performing audits to identify discrepancies and improve processes
Familiarity with servicing systems, such as Black Knight or similar platforms
Excellent problem-solving skills with the ability to address borrower disputes and escrow discrepancies
Knowledge of federal and state regulations related to mortgage servicing
Strong organizational skills and attention to detail for maintaining accurate records
Ability to collaborate effectively with internal teams and external parties such as tax authorities and insurance providers

Job Responsibility

Process loan payments and manage customer accounts, ensuring all updates are accurate, timely, and compliant
Administer and analyze escrow accounts, including tax and insurance disbursements, while maintaining full regulatory compliance
Conduct detailed audits of loan and escrow records to verify proper setup, complete payment histories, and adherence to federal, state, and investor guidelines
Analyze data related to escrow shortages, overages, delinquency trends, and servicing exceptions, identifying root causes and recommending actionable solutions
Maintain precise, up-to-date loan records within Black Knight MSP, ensuring the highest level of data integrity
Investigate and resolve escrow discrepancies and borrower disputes with professionalism and accuracy
Coordinate with tax authorities, insurance carriers, and internal teams to ensure timely, accurate disbursements
Reconcile escrow accounts and support month-end reporting, balancing, and audit preparation
Ensure all servicing activities align with company policies, investor requirements, and regulatory standards
Recommend process improvements to enhance accuracy, operational efficiency, and audit readiness

What we offer

medical, vision, dental, life and disability insurance, 401(k) plan

Fulltime

Senior Regulatory Affairs Specialist

Reporting to the Senior Manager, Regulatory Affairs within the RA Department, th...

Location

United States , St Louis

Salary:

74000.00 - 90000.00 USD / Year

STERIS

Expiration Date

Until further notice

Requirements

Bachelor's Degree
At least 5 years professional experience including regulatory affairs, quality systems, internal auditing, applicable scientific or technical functions
Self-starter with demonstrated organizational, project management, time management and problem-solving skills
Experience working effectively on cross-functional teams
Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
Excellent PC skills, including Microsoft Office applications including Excel, Word and PowerPoint
Understanding of chemical / scientific industry
Experience with internal audit process and quality systems
Experience with Healthcare regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries

Job Responsibility

Identify regulatory requirements for new products or product enhancements early in the product development cycle
Assure that product registration and maintenance fees are tracked and paid
Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims
Review product revision requests to assure compliance with regulatory requirements
Work on product teams to develop regulatory strategy based on regulatory submission requirements
Review and approve labeling and marketing literature
Support Manager, Regulatory Affairs and other Regulatory Affairs staff with all regulatory matters
Provide Regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries to the Healthcare team
Work with direct Supervisor and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management
Other duties as assigned

What we offer

Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term care

Fulltime

Regulatory Support Specialist

Uber

Location:
Australia , Sydney

Category:
Customer Service

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 01, 2026

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