Senior Gas Pipeline Compliance Analyst maintaining safe, reliable natural gas operations at Enbridge. Analyzing regulations and partnering with teams for federal and state compliance.
About the role
- Regulatory Affairs Specialist overseeing regulatory submissions in SEA for global medical device company. Ensuring compliance and managing stakeholder communications for product regulations.
Responsibilities
- Responsible for the daily operations of regulatory affairs and assures regulatory submissions meet local and regional compliance requirements
- Staying abreast with regulatory compliance requirements and changes affecting company operations and products
- Generates and manages submission documents for new products or changes to existing regulatory submissions
- Performing analysis of change assessments to provide regulatory impact and associated information to the global change management team
- Maintaining accurate and complete change information to demonstrate traceability of changes
- Preparing and compiling submission dossiers for reportable changes
- Acting as primary contact regarding changes and ensure changes are understood by relevant stakeholders
- Writing, preparing, submitting regulatory documents for the South-East Asia (SEA) market (Arthrex distributor and subsidiary)
- Communicating with regulators on submission projects
- Prioritising and organising multiples projects with competing priorities
- Participating in regulatory affairs planning for SEA markets
- Providing support in APAC level projects as and when needed
- Reviewing product labelling and Directions for Use (DFU), if any translation is required
- Supporting product safety alert activities and field actions
- Assisting in activities relating to post market surveillance (i.e. Complaints, Performance Evaluation Reporting (PER), Adverse Event Reporting (AER), and/or liaising with Regulatory bodies in assigned countries)
Requirements
- Degree qualified preferably in an Engineering or Science discipline
- Minimum 3-4 years direct RA experience within a medical device company
- Strong working knowledge of SEA medical device regulations and standards
- Knowledge of global regulations will be advantageous
- Excellent interpersonal skills, with proven ability to effectively communicate and form strong relationships with stakeholders across all levels
- Ability to work both independently and as part of a team to effectively contribute in both individual and collaborative settings
- Ability to manage multiple tasks and prioritize work in a dynamic, fast paced environment
- Comprehension of technical, engineering or medical terminology, and/or ability to reference literature for understanding
- Technical skills in manufacturing or design relating to regulatory affairs will be advantageous
- PC, database, research tools, internet research tools
- MS Office skills (Word, Excel, PowerPoint, Outlook)
Benefits
- Proactively attending seminars, lectures and academic conferences
- Ongoing Education and Training
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Regulatory Analyst managing compliance obligations associated with regulatory requirements at Tallgrass, an energy infrastructure company. Involved in preparation, analysis, and administration in relevant areas.
Trainee supporting product compliance and legal regulation at ZF, engaging in training activities and various legal assistance tasks. Collaborating with experts on compliance projects.
Working Student supporting the VATrules Team with data management and documentation processes. Engaging in VAT compliance and improving data structures in a hybrid work environment.
VAT Compliance Specialist managing VAT - relevant data and ensuring compliance in an international team. Collaborating with various departments to maintain data quality and support documentation processes.
Specialist II in Regulatory Affairs preparing and maintaining global submissions for conducting clinical investigations. Collaborating with engineering and regulatory teams to ensure compliance with worldwide regulations.
Senior Lead Expert Regulatory managing bank regulatory communication and requirements at leading German bank LBBW. Overseeing compliance, analysis, and decision - making within financial regulatory frameworks.
Regulatory Affairs Manager overseeing compliance of food products and processes. Collaborating with teams to drive regulatory strategies and maintain product quality standards at Bel.
Chief Compliance Officer establishing risk management and compliance frameworks for Sezzle Bank ILC. Managing regulatory compliance and risk in financial services with a focus on BSA/AML and OFAC.
Regional Sustainability Compliance Manager leading product compliance activities across the Americas for ACT Group. Ensuring renewable energy products meet regulatory and sustainability certification requirements.