CrawlJobs Logo

Raqa Manager

karlstorz.com Logo

KARL STORZ

Location Icon

Location:
Philippines , Taguig City

Category Icon
Category:
Health and Beauty

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Responsibility:

  • Ensure company operations comply with applicable regulatory requirements, including FDA Philippines regulations and other relevant government standards
  • Prepare, compile, and submit regulatory dossiers and applications (registrations, notifications, variations, and reports) to the FDA Philippines in accordance with regulatory timelines and company requirements
  • Manage post-market surveillance activities, including monitoring and reporting of complaints, adverse events, CAPA, FSCA, and product recalls until proper closure and documentation
  • Support and maintain the ISO 9001:2015 Quality Management System, including participation in Internal Quality Audits (IQA), preparation of Corrective Action Reports (CAR), process documentation, and contribution to Management Review activities
  • Serve as the liaison between regulatory authorities and internal departments, responding to regulatory inquiries and ensuring timely communication of regulatory requirements to relevant stakeholders
  • Provide regulatory guidance and technical support to internal teams and third-party distributors to ensure compliance with regulatory and company standards
  • Develop and maintain departmental procedures, standards, and documentation to ensure efficient regulatory and quality processes
  • Provide regulatory intelligence by monitoring regulatory developments, guidance updates, and enforcement trends, and translating these into actionable recommendations for internal and external stakeholders
  • Coordinate with operations and cross-functional teams regarding technical product information and regulatory compliance requirements
  • Support regional RA/QA in driving cross-functional regional strategic initiatives and shared services to strengthen regulatory compliance, quality system effectiveness, process harmonization, and overall operational excellence across Southeast Asia + Taiwan (SEAT) region
  • Perform other duties related to regulatory affairs and quality assurance as required to support business and compliance objectives
  • Review of Ethical Marketing and Compliance Programs, ensuring alignment with the APACMed Code of Conduct, company policies, and applicable healthcare compliance regulations
  • Drive risk management initiatives by identifying, assessing, and mitigating potential compliance risks related to commercial activities, third-party engagements, and operational processes
  • Act as the primary liaison for legal and compliance documentation, including Distributor Agreements, Accreditations, and Third-Party Due Diligence, coordinating with internal stakeholders and regional/legal teams to ensure proper review and compliance
  • Oversee third-party compliance management, including onboarding, due diligence reviews, and risk assessments for distributors, vendors, and business partners
  • Conduct compliance orientation and training programs for third-party vendors and distributors, anti-corruption requirements, and company compliance policies
  • Provide advisory support to internal teams on compliance matters related to marketing activities, sponsorships, engagements with healthcare professionals (HCPs), and external partnerships

Requirements:

  • Must possess Bachelor's/College Degree in Pharmacy (Pharmacy/Pharmacology) or equivalent
  • Licensed Pharmacist
  • Minimum 7 years' working experience in the Regulatory Affairs Medical Device industry
  • with at least 2 years of management experience
  • Extensive knowledge of applicable local government regulations
  • Strong understanding of ASEAN Medical Device Directive (AMDD) and EU Medical Device Regulation (MDR)
  • Good working knowledge of Good Distribution Practice (GDP) and ISO 9001
  • experience with audits, inspections, and QMS implementation is essential
  • Ability to inform and educate managers and department heads on regulations and polices that require regulatory affairs compliance
  • Excellent written and verbal communication skills
  • Excellent analytical and problem-solving skills
  • Excellent strategic planning skills
  • Proficient with applicable database and compliance software
  • Proficient with Microsoft Office Suite or required software
What we offer:
  • Leave Benefits (Vacation Leave, Sick Leave, Parental Leave, etc.)
  • Birthday Benefits
  • Transport Allowance (if applicable to role)
  • Accessibility to Public Transport
  • Flexible Work Arrangements
  • Group Health Insurances (with 2 additional dependents)
  • Wellness Programs and Activities
  • Professional Development Opportunities
  • Global Exposure & Business Travel Opportunities (if applicable to role)
  • All other statutory benefits

Additional Information:

Job Posted:
March 25, 2026

Work Type:
Hybrid work
Icon
KARL STORZ - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Raqa Manager

Senior RA/QA Executive, APAC

Senior RA/QA Executive, APAC (m/f/d) at KARL STORZ. Job Function: Quality Manage...
Location
Location
Singapore , Singapore
Salary
Salary:
Not provided
karlstorz.com Logo
KARL STORZ
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Recognised Diploma/Degree in Life Sciences, Engineering, Regulatory or related field
  • 3-4 years of experience in RAQA within the medical device industry
  • Experience working in a regional or multi-country environment with cross-functional teams
  • Excellent organizational, analytical, and communication skills
  • Strong interpersonal and communication skills
  • Meticulous attention to details
  • Good time management skills are highly essential
Job Responsibility
Job Responsibility
  • Regulatory Submissions & Change Notification Governance: Coordinate and track timely submissions for product registrations, renewals, and variations across Asia. Own the end-to-end process for regulatory change notifications, ensuring impact assessments, documentation readiness, and submission tracking in partnership with country RAQA and global teams
  • Regulatory Intelligence, Labelling & UDI Compliance: With the support of local RAQA, monitor evolving Asia regulations and provide strategic insights on labelling and UDI requirements. Support impact assessments, update SOPs/templates, and disseminate regulatory intelligence to country teams to ensure compliance and traceability
  • Complaint Handling, FSCA & Recall Execution: Lead regional coordination of complaint intake, triage, and resolution. Manage FSCA and recall processes, ensuring timely execution, regulatory reporting, and effective field actions in collaboration with Quality, Supply Chain, and Commercial teams
  • Post-Market Surveillance (PMS) Strategy & Vigilance: Monitor and analyse PMS data trends to identify emerging risks. Lead regional input into global PMS reports, risk assessments, and vigilance submissions. Ensure compliance with local adverse event reporting and surveillance requirements
  • Data Management, Reporting & Transparency: Maintain dashboards and trackers for regulatory submissions, PMS, quality metrics, and compliance status across APAC markets. Provide regular reporting to regional and global stakeholders to support visibility and decision-making
  • Process Harmonization & Continuous Improvement: Drive harmonization of RA and PMS processes across Asia, aligning with global standards. Identify and implement process improvements to enhance efficiency, compliance, and visibility. Develop SOPs, templates, and governance tools to support consistent execution
  • Training, Capability Building: Develop and deliver training programs on regulatory change, vigilance, and PMS processes. Act as a regional resource for country RAQA teams, providing coaching and escalation support
  • Ad-Hoc Regional Support & Escalations: Serve as a flexible point of contact for subsidiary-level needs intersecting with regional objectives. Provide timely assistance for emerging projects, pilot programs, authority inquiries, and urgent compliance matters as directed by the Regional RAQA Director or global RAQA teams
What we offer
What we offer
  • Leave Benefits (Vacation Leave, Sick Leave, Parental Leave, etc.)
  • Birthday Benefits
  • Transport Allowance (if applicable to role)
  • Accessibility to Public Transport
  • Flexible Work Arrangements
  • Group Health Insurances
  • Flexi-Benefit Reimbursement
  • Wellness Programs and Activities
  • Professional Development Opportunities
  • Global Exposure & Business Travel Opportunities (if applicable to role)
  • Fulltime
Read More
Arrow Right

Customer Outreach Specialist

Customer Outreach Specialists will be responsible for providing customer service...
Location
Location
United States , Houston
Salary
Salary:
17.50 USD / Hour
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School diploma or equivalent
  • 2+ years experience in Customer Service, Call Center, or related function
  • Excellent multitasking and organization skills
  • Excellent verbal and written communication skills
  • Excellent customer service skills
  • Excellent computer skills including proficiency in MS Office suite, including MS Excel and MS Outlook
  • Patience, professionalism, and excellent phone etiquette
  • Expected to be available on-site during scheduled work hours
  • Ability to list 30-40 lbs
  • Ability to sit for extended periods of time
Job Responsibility
Job Responsibility
  • Managing inbound and outbound phone calls, e-mails, and text-messages with customer accounts, patients, and other stakeholders
  • Perform investigation into patient and customer contacts to successfully perform outbound calling operations
  • Verify and document all patient and customer identities per HIPAA and other Federal regulations
  • Demonstrate a high level of empathy and skill in all interactions with patients, customers, and internal partners
  • Perform tasks to support the completion, return, and upload of CAM studies
  • Assist patients and customers with shipping and product logistics
  • Assist patients with the setup and application of their CAM device
  • Provide patient instruction and guidance regarding medical device usage and interaction with Emergency services
  • Assist customers with CAM issue investigation and resolution
  • Assist in operations under all branches of Customer Outreach, as required
What we offer
What we offer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Educational assistance programs
  • Paid holidays
  • Paid time off ranging from 20 to 35 days based on length of service
  • Family and medical leaves of absence
  • Paid parental leave
  • Fulltime
Read More
Arrow Right

Business Development Associate

This role is responsible to drive sales, expand market share and increase produc...
Location
Location
Singapore
Salary
Salary:
Not provided
avanos.com Logo
Avanos
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Candidate with Nursing, Biomedical, Biotechnology or Science background preferred
  • At least 5 years of experience in related experience
  • Track record of profit/margin maximization, revenue growth, execute programs, manage projects and campaigns
  • Possess product training experience to clinical users and distributors
  • Strong understanding and identification of customers and their needs, clinical environment, competitive landscape and trends
  • Experience creating clinical acceptance and drive adoption of new treatments/therapies/technologies
  • Broad-based knowledge of medical consumables sales and marketing processes
  • Highly self-motivated, results-oriented with a drive and passion to succeed
  • Exceptional people skill and customer service oriented
  • Good communication and presentation skills
Job Responsibility
Job Responsibility
  • Drive sales, expand market share and increase product branding and awareness for the Company’s best-in-class products and business in assigned markets within Central Asia, mainly in Singapore
  • Participate in clinical cases, cadaver workshops and conferences
  • Perform equipment in-service maintenance and monitoring
  • Deliver product trainings to internal and external stakeholders e.g. sales team, physicians, clinical users, distributors, etc. to ascertain a solid understanding of AVANOS products, relevant technologies and application
  • Support operating procedures in the hospitals
  • Work closely with the Business Development Manager, Central Asia, ASEAN Sales Team, APAC Marketing Team to ensure the alignment of global, regional and local strategies, with the aim to elevate the company’s brand and improve product adoption efficacy through driving demand, sales and market expansion in the assigned markets
  • Work closely with cross-functional teams to own and drive customer satisfaction, product compliance, innovation and margin improvement
  • Be responsible for leading and building the Avanos Pain business mainly in Singapore
  • Achieve and exceed regional sales and financial budget and operational objectives
  • Drive growth on strategic focus products via increasing brand awareness and customer loyalty to Avanos products
What we offer
What we offer
  • Comprehensive and competitive range of benefits
  • Total Rewards package encompasses everything you receive as an employee
  • your pay, health care benefits, retirement plans and work/life benefits
Read More
Arrow Right

Quality System Specialist

Bio-Rad’s Global Quality Management Systems (QMS) team seeks a highly skilled an...
Location
Location
Hungary , Budapest
Salary
Salary:
Not provided
bio-rad.com Logo
Bio-Rad Laboratories
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in quality management, business administration, or a similar field
  • 3 or more years’ experience managing an electronic system within a regulated industry, preferably a QMS application for processes such as document management, CAPA, change control or similar
  • Veeva platform a plus
  • Experience with system software validation highly desired
  • Experience within the IVD, medical device or similarly regulated industry highly desired
  • Excellent attention to detail and problem-solving skills
  • Ability to comfortably work both independently and collaboratively with internal business/technical team members from around the world
  • Exceptional communication skills are essential
  • Ability to travel as needed (infrequent)
Job Responsibility
Job Responsibility
  • Support the development, governance and maintenance of the Veeva platform in support of the organization’s Quality Management System in partnership with the IT System Administrator
  • Support cross-functional partners to manage Veeva applications (current and future)
  • Manage the incident and change request logs and develop mechanisms for review, approval/rejection, prioritization and communication of implemented changes to stakeholders and system users
  • Partner with stakeholders and vendors to implement and validate new applications, scheduled updates, and approved changes for movement into production
  • Provide training and support to end-users to ensure proficient use of the Veeva platform and adherence to established processes
  • Maintain system documentation, including system technical specifications and test scripts, standard operating procedures, user guides and training materials specific to the Veeva platform
  • Track and report on system performance, providing insights and recommendations for continuous improvement
  • Respond to system and process inquiries to support RAQA teams such as for audits and inspections
What we offer
What we offer
  • Life and accident insurance
  • Private Health Care Services – unlimited examinations, checkups in numerous specialties free of charge
  • Competitive salary and cafeteria
  • 100% commuting allowance for non-Budapest residents, monthly BKK pass
  • Annual bonus
  • Annual salary review
  • Marriage and childbirth allowance
  • School start allowance
  • Loyalty award
  • Employee Referral Program with remarkable referral bonus
Read More
Arrow Right
New

Front Office Executive

Role: Front Office Executive Core Responsibilities Administrative Support: Handl...
Location
Location
India , Mumbai
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
July 02, 2026
Flip Icon
Requirements
Requirements
  • 5 years of experience
Job Responsibility
Job Responsibility
  • Handle filing, data entry, scanning, photocopying, and faxing
  • Organize meetings, manage appointment calendars, and schedule conference rooms
  • Keep the reception area clean, organized, and equipped with necessary materials
  • Maintain visitor logs, issue temporary access badges, and follow safety procedures
  • Monitor inventory of office supplies and place orders when needed
  • Greet, welcome, and direct visitors and clients promptly, ensuring a professional image
  • Answer, screen, and forward incoming phone calls while managing emails and letters
  • Fulltime
Read More
Arrow Right
New

Transport Supervisor

As the Transport Supervisor, you will support and manage an efficient, effective...
Location
Location
United Kingdom , Brighton
Salary
Salary:
Not provided
jobs.360resourcing.co.uk Logo
360 Resourcing Solutions
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience of different logistics operations
  • Experience gained within a B2C multi drop, multi temperature operation
  • A confident decision maker with the ability to effectively follow through and execute decisions made
  • Highly organised and exceptional planning skills with the ability to manage and prioritise various tasks
  • Strategic problem solving ability, capable of re-working situations if plan change with minimal impact to the business
  • Significant experience of delivering both excellent Customer Service and Customer satisfaction results
  • Commercially focused and committed to achieving targets
  • The ability to give clear direction
  • Excellent verbal and written communication skills
  • Excellent listening skills
Job Responsibility
Job Responsibility
  • Develop a positive and united team culture
  • Ensure clear communication in a timely manner in relation to the allocation of team member duties
  • Coordinate the balance of activities within the Delivery Centre / Hub across functions to ensure synchronised marshalling and loading is kept with Picking and Replenishment
  • Manage and maintain asset management procedures in relation to the return of cages, totes, pallets and other delivery tools
  • Manage and maintain the vehicle routing application (Paragon) for optimal results
What we offer
What we offer
  • Competitive hourly rate
  • Pension
  • 22 days annual leave
  • Onsite parking
  • Fulltime
Read More
Arrow Right
New

Receptionist

The Receptionist will serve as the first point of contact for visitors and calle...
Location
Location
United States , Eagan
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or equivalent
  • additional qualifications in office administration are a plus
  • proven experience as a receptionist, front office representative, or similar role
  • excellent verbal and written communication skills
  • proficiency in Microsoft Office Suite (Word, Excel, Outlook) and office equipment (e.g., fax machines, printers)
  • strong organizational and multitasking skills
  • professional appearance and demeanor
  • ability to maintain confidentiality and handle sensitive information
  • positive attitude and ability to work well in a team environment
  • good time-management skills and ability to prioritize tasks
Job Responsibility
Job Responsibility
  • Greet and welcome visitors in a professional and friendly manner
  • answer and direct phone calls to the appropriate staff members
  • manage the reception area, ensuring it is clean, organized, and presentable
  • receive and distribute mail, packages, and deliveries
  • assist with scheduling appointments and meetings
  • maintain visitor logs and issue visitor badges
  • provide general administrative support, including data entry, filing, and photocopying
  • respond to inquiries and provide information about the company
  • assist with special projects and other duties as assigned
What we offer
What we offer
  • Medical, vision, dental, and life and disability insurance
  • enrollment in company 401(k) plan
  • access to top jobs
  • competitive compensation
  • free online training
  • Fulltime
Read More
Arrow Right
New

Lead/Staff Platform Engineer

We are currently seeking a Lead/Staff Platform Engineer to join our team remotel...
Location
Location
United States , Worcester
Salary
Salary:
111172.00 - 131700.00 USD / Year
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 1+ years coding in either Python, Typescript, or Golang
  • 1+ years scripting experience in bash or powershell
  • 5+ years of networking experience (security, DNS, VPN, Cloud, load balancing)
  • 5+ years of systems administration experience with at least one operating system (Linux or Windows)
  • 3+ years experience with one of the following public cloud platforms (AWS, Azure, or GCP)
Job Responsibility
Job Responsibility
  • Quickly be steeped in a suite of custom accelerators which include: Continuously tested & delivered Infrastructure, Pipeline, and Policy as Code
  • Extensible automation & dependency management code frameworks
  • Development of event driven functions, APIs, backend services, Command Language Interfaces, and Self-Service Developer Portals
  • We eat our own dog food
  • all your work will be covered with unit, security, governance, and functional testing utilizing appropriate frameworks
  • Armed with these accelerators you will be among the first on the ground to customize and deploy the delivery platform that will enable the application developers that follow us to rapidly create, demonstrate, and deliver value sprint over sprint for much of the Global Fortune 500
What we offer
What we offer
  • medical insurance
  • dental insurance
  • vision insurance
  • employer contribution
  • flexible spending or health savings account
  • life and AD&D insurance
  • short and long term disability coverage
  • paid time off
  • employee assistance
  • participation in a 401k program with company match
  • Fulltime
Read More
Arrow Right