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4,867
Risk Management jobs in Singapore
Medical Affairs Executive
BIOPTIMAL INTERNATIONAL PTE. LTD.
Singapore
On-site
SGD 80,000 - 100,000
2 days ago
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Assistant Manager, Medical Affairs - Clinical Governance(9345) - Alexandra Hospital
NATIONAL UNIVERSITY HEALTH SYSTEM PTE. LTD.
Singapore
On-site
SGD 20,000 - 60,000
2 days ago
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Project Supervisor (Process Sector)
ASTON ENGINEERING & MAINTENANCE PTE. LTD.
Singapore
On-site
SGD 45,000 - 65,000
2 days ago
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Compliance Officer
BIDSVENTURE GLOBAL HOLDING PTE. LTD.
Singapore
On-site
SGD 80,000 - 110,000
Today
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Cyber Security Analyst ( Associate)
FLINTEX CONSULTING PTE. LTD.
Singapore
On-site
SGD 40,000 - 60,000
Today
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Discover more opportunities than anywhere else. Find more jobs nowSenior AVP, Clearing & Risk Management: Strategy Lead
EUREX FRANKFURT AKTIENGESELLSCHAFT Singapore Branch
Singapore
On-site
SGD 60,000 - 80,000
Today
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VP/SVP, End User Infrastructure Security & Engineering Lead, Technology Group (16847)
GIC PRIVATE LIMITED
Singapore
On-site
SGD 120,000 - 160,000
Today
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A&A - VN - ITDA - Senior Manager
Deloitte PLT
Singapore
On-site
SGD 120,000 - 160,000
Today
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Connect with headhunters to apply for similar jobsChief Risk & Compliance Leader - Asset Management
AIA Singapore
Singapore
On-site
SGD 150,000 - 250,000
Yesterday
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Associate Security Analyst II, Incident Response
Hispanic Alliance for Career Enhancement
Singapore
On-site
SGD 60,000 - 80,000
Yesterday
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Senior Social Worker
Buddhist Compassion Relief Tzu-Chi Foundation (Singapore)
Singapore
On-site
SGD 20,000 - 60,000
Yesterday
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SEA SR&T Quality & Risk Manager
Deloitte PLT
Singapore
On-site
SGD 80,000 - 120,000
Yesterday
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Process Engineer
UNIMATEC SINGAPORE PTE. LTD.
Singapore
On-site
SGD 50,000 - 70,000
Yesterday
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Senior / Lead Commissioning Engineer (Instrument)
SEATRIUM (SG) PTE. LTD.
Singapore
On-site
SGD 80,000 - 100,000
Yesterday
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Cloud Security Engineer
Unison Consulting Pte Ltd
Singapore
On-site
SGD 60,000 - 80,000
Yesterday
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Senior Chartering Specialist
ANGLO AMERICAN MARKETING LIMITED Singapore Branch
Singapore
On-site
SGD 100,000 - 130,000
2 days ago
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District Lead (Admin), District South
Public Service Division
Singapore
On-site
SGD 70,000 - 90,000
2 days ago
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Front KYC Advisory Specialist
SCB-JULIUS BAER (SINGAPORE) PTE. LTD.
Singapore
On-site
SGD 70,000 - 90,000
2 days ago
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Senior Officer/Manager, Credit Analyst
United Overseas Bank
Singapore
On-site
SGD 50,000 - 70,000
2 days ago
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MSAT Engineer (UF/DF) - Contract
No deviation
Singapore
On-site
SGD 80,000 - 100,000
2 days ago
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Medical Affairs Executive
BIOPTIMAL INTERNATIONAL PTE. LTD.
Singapore
On-site
SGD 80,000 - 100,000
Full time
2 days ago
Be an early applicant
Job summary
A leading medical device company in Singapore is seeking a professional for clinical evaluation roles in invasive catheter and cardiology devices. Candidates should have a degree in medical or life sciences, at least 5 years of relevant experience, and strong regulatory knowledge. Responsibilities include ensuring compliance with MDR guidelines, handling technical documentation, and participating in clinical strategies. The ideal candidate is analytical, detail-oriented, and possesses excellent communication skills.
Qualifications
- 5 years professional experience in clinical evaluation of invasive catheter or cardiology medical devices.
- Working knowledge of regulatory requirements related to clinical evaluation.
- Fluency in English with strong technical writing skills.
Responsibilities
- Provide clinical expertise in evaluations according to MDR 2017/745 guidelines.
- Create and update technical documentation as per MDR requirements.
- Plan and implement clinical strategies adhering to applicable regulations.
Skills
Regulatory requirements knowledge
Research methodology
Technical writing
Data-driven analysis
Interpersonal skills
Education
Degree in medical or life science
PhD (added advantage)
Tools
Embase
Medline
PubMed
Job description
JOB DESCRIPTION
- Provide clinical expertise in clinical evaluation, and literature search and appraisal technical documentation according to MDR 2017/745 and MEDDEV guidelines.
- Provide clinical expertise in post-market clinical follow-up (PMCF) and post-market surveillance (PMS) technical documentation including the creation and update of the Summary of Safety and Clinical Performance (SSCP) according to MDR 2017/745 and MDCG guidelines.
- Provide safety and clinical assessment of complaints and adverse events including technical write-up of the manufacturer’s incident report (MIR).
- Create, review and update procedures, work instructions, protocols and reports related to clinical evaluation, literature search and appraisal, post-market clinical follow-up (PMCF), post-market surveillance (PMS) and Summary of Safety and Clinical Performance (SSCP) according to current standards and guidance, and periodic schedule.
- Participate in the risk management team and provide safety and clinical assessment in the risk management file (RMF) on identified risks from different data sources during post-production processes that is in accordance with the requirements of ISO 14971.
- Provide support in the MDR documentation, application, submission and review as and when needed by the superior.
- Provide support in the creation, update and maintenance of the technical files according to MDR 2017/745 requirements.
- Perform market research and analysis on clinical trials and product outlook from different online sources.
- Provide support on the internal audits and external certification audits in compliance with ISO 13485, other applicable standards and regulations.
- Plan, develop and implement clinical strategies in accordance with applicable guidance, standards and regulations.
- Interface with Bioptimal’s contracted manufacturer on the clinical needs of the company and the strategies to obtain compliance to applicable guidance, standards and regulations.
- Act as Singapore representative in communicating the clinical needs to different stakeholders and obtaining approval on clinical evaluations.
- Take lead in the creation, update, execution, follow-up and compiling of clinical surveys according to procedure.
REQUIREMENTS
- Degree in medical or in life science with at least 5 years professional work experience in invasive catheter or cardiology related medical devices’ clinical evaluation, with PhD is an added advantage.
- Working knowledge on regulatory requirements relating to clinical evaluation is a must, with MDR 2017/745 background is an added advantage.
- Preferably with good research methodology (including clinical investigation design and biostatistics).
- Must be scientific and data-driven with good information management (experience with relevant databases such as Embase, Medline, PubMed, etc.)
- Fluent and experienced in technical writing related to clinical evaluation and literature search and appraisal.
- Fluent in both verbal and written English.
- With high level of integrity and able to work on tight deadlines and deliver results as per schedules.
- Self-starter, independent, analytical thinker and able to recommend sound, logical advice to management in accordance with applicable regulations and guidance.
- With good interpersonal and communication skills, positive outlook and able to get along with peers.
* 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.