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1,539

Corporate jobs in United States

Senior Regulatory Affairs Specialist

Haemonetics

Simpang Ampat
On-site
MYR 80,000 - 120,000
27 days ago
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Associate-Liquidity Solutions

AIA Hong Kong

Cyberjaya
On-site
MYR 60,000 - 80,000
27 days ago

Data Engineer

Love

Kuala Lumpur
On-site
MYR 70,000 - 90,000
27 days ago

Equipment Maintenance Technician

Renesas Electronics

Bayan Lepas
Hybrid
MYR 20,000 - 100,000
27 days ago

Accounting Leader East Asia Pacific

Doka GmbH

Petaling Jaya
On-site
MYR 120,000 - 180,000
27 days ago
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Senior Flow Assurance Engineer

McDermott International,

Kuala Lumpur
On-site
MYR 120,000 - 180,000
27 days ago

Account Receivable Specialist (Mandarin Speaker)

Baxter International

Kuala Lumpur
On-site
MYR 165,000 - 248,000
27 days ago

Manager, Category Managment

Ultra Clean Technology

Simpang Ampat
On-site
MYR 120,000 - 160,000
27 days ago
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Equity Research Analyst | Utilities & Construction

Macquarie Bank Limited

Kuala Lumpur
On-site
MYR 80,000 - 120,000
27 days ago

Equipment Engineer

Renesas Electronics

Bayan Lepas
Hybrid
MYR 36,000 - 48,000
27 days ago

Lead Counsel

Respond.io

Kuala Lumpur
On-site
MYR 190,000 - 300,000
27 days ago

Assistant Communications Manager — Malaysia (Hybrid PR & Media)

Grab

Petaling Jaya
On-site
MYR 80,000 - 120,000
27 days ago

Accounts Payable Specialist II: T&E & Card Programs

Zebra Technologies

Simpang Ampat
On-site
MYR 100,000 - 150,000
27 days ago

Murex Market Risk Consultant

Luxoft

Kuala Lumpur
On-site
MYR 80,000 - 110,000
27 days ago

Murex Back Office Consultant

Luxoft

Kuala Lumpur
On-site
MYR 120,000 - 160,000
27 days ago

[Web3] Junior Operations Support Associate (Mandarin-speaking)

BTSE

Malaysia
On-site
MYR 20,000 - 100,000
28 days ago

A&A - MY - ERS Consultant / Manager (Board Advisory)

Deloitte PLT

Kuala Lumpur
On-site
MYR 80,000 - 110,000
28 days ago

Assistant Director of Safety & Security (Pre Opening) - Waldorf Astoria

Hilton Worldwide, Inc.

Kuala Lumpur
On-site
MYR 150,000 - 200,000
28 days ago

B2B Customer Support Officer, Kuala Lumpur

Emerald Zebra

Kuala Lumpur
On-site
MYR 100,000 - 150,000
28 days ago

Finance Executive

Spirax-Sarco Engineering

Shah Alam
On-site
MYR 60,000 - 80,000
28 days ago

APAC Compensation Manager (1 year contract)

Elanco

Petaling Jaya
On-site
MYR 100,000 - 150,000
28 days ago

Business Analyst, Finance Controlling

AstraZeneca

Petaling Jaya
On-site
MYR 80,000 - 120,000
28 days ago

Business Intelligence (BI) Team Lead

StoreHub

Kuala Lumpur
On-site
MYR 100,000 - 150,000
28 days ago

Early Career - Advanced Process Control Applications Engineer

Exxon Mobil

Kuala Lumpur
On-site
MYR 70,000 - 90,000
28 days ago

Tax - Corporate Tax Compliance (GCR), Experienced Associate / Senior Associate (Kuching)

Ernst & Young Advisory Services Sdn Bhd

Kuching
On-site
MYR 150,000 - 200,000
28 days ago
Senior Regulatory Affairs Specialist
Haemonetics
Simpang Ampat
On-site
MYR 80,000 - 120,000
Full time
27 days ago

Job summary

A leading global healthcare company in Malaysia is seeking a Regulatory Affairs professional responsible for ensuring compliance across Asia Pacific. The role involves developing regulatory strategies, managing documentation for licenses, and coordinating with various departments. Ideal candidates should have a degree in Engineering or Science, and a minimum of 3 years of experience in a manufacturing environment.

Qualifications

  • Minimum 3 years working experience in manufacturing environment.

Responsibilities

  • Direct activities to ensure compliance with local regulations.
  • Develop and implement all phases of regulatory strategy.
  • Provide regulatory authorities with documentation for licenses.
  • Establish relationships with external partners and regulators.
  • Collaborate with departments to compile tech info for regulatory submissions.
  • Review labeling changes for regulatory impact.
  • Train employees on regulatory requirements and practices.
  • Communicate with customers to respond to regulatory concerns.
  • Maintain product registration data base for various regions.
  • Manage communication on vigilance issues for assigned countries.

Skills

Problem solving
Root cause analysis
Statistical analysis

Education

Degree in Engineering or Science discipline
Job description
Job Details

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Summary:

Responsible for directing activities to ensure compliance with local regulations within Asia Pacific countries.

Job Responsibilities:
  • Responsible initiate, develop and implement all phases of regulatory strategy to ensure necessary approvals for company products/services.
  • To provides regulatory authorities with appropriate documentation in the aim of obtaining licenses and regulations.
  • To Establishes and maintains relationships with external partners, regulators and opinion formers. Responsible for following regulatory activities at local level.
  • Responsibilities encompass to work with corporate RA, R&D, Marketing, Legal, Business Leader and any other relevant distribution department to compile technical information for supporting regulatory submissions for the countries of the region.
  • Review proposed labeling changes to determine regulatory impact on existing certifications and registrations.
  • Work with RA staff, clinical staff and program managers to develop regulatory approval strategies for products and project prioritization.
  • Conduct training programs to educate employees on regulatory requirements and good regulatory practices.
  • Review new regulatory guidance and participate in the implementation of programs to support compliance
  • Communicate with customers to respond to regulatory concerns/questions.
  • Maintain product registration data base for Hong Kong, Taiwan, South/East Asia and India Subcontinent & Distribution countries track regulatory department metrics
  • Manage communication about vigilance issues for assigned countries.
Job Requirement:
  • Degree in Engineering or Science discipline or equivalent
  • Minimum 3 years working experience in manufacturing environment
  • Knowledge in problem solving, root cause and statistical Analysis

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* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.

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