Global Medical Device Reporting Specialist
4 days ago
We are seeking a highly skilled Global Medical Device Reporting Specialist to join our team at Lifelancer.
Job DescriptionThe successful candidate will be responsible for ensuring compliance with national and international regulations, as well as regulatory agency requirements, by designing and developing product safety procedures and monitoring strategies. They will also create programs and processes to respond to audits and safety inspections, deliver reports to management and external regulatory agencies, and participate in IVDR deliverables and gap analysis.
In this role, you will be accountable for oversight of safety in clinical trials and post-marketing programs, developing and delivering training programs to educate the organization on medical and vigilance topics, including complaint definitions, reportable events, and timeliness requirements.
Key Responsibilities- Reporting of MedWatch, MIR, MDPR, and other regulatory forms as required
- Ensure product concerns are investigated to determine if vigilance reporting is required
- Support local and regional vigilance activities as requested and determined by the Vigilance team manager
- Assist the complaints team on a needs basis, including investigational guidance, complaint processing, and quality assessments
- Support daily operations in terms of vigilance evaluations, escalations of NCRs, and product investigations raised locally
- Ad hoc participation in CAPA activities related to vigilance and complaints
- Preferably an M.Sc. or B.Sc. degree in a scientific or technical discipline or other relevant technical education
- 4+ years of experience
- Experience with vigilance documentation/activities relating to Medical Device Reporting
- Ability to interpret regulatory standards, guidance, and laws
- Strong written and oral communication skills (in English) to a global organization, including contact with distributors
- Thoroughly versed in Quality System Standards e.g. ISO 13485, FDA CFR 21 Part 803, 806, and 820, and similar global regulations, including preferably IVD/Medical Device legislation in the USA (MDR) and EU (MEDDEV)
- Track record of applying good judgment in determining if reported issues and complaints are reportable based on IVD/Medical Devices or similar legislation
- Skilled in effectively and efficiently documenting events and findings
- Experience with data analysis, troubleshooting, problem-solving in compliance with regulation and presentation of results
- Demonstrate ability to collaborate across different functions
- Preferably antibody, probe production, and QC knowledge (IHC, ISH), knowledge of instrumentation used for IHC and ISH tests
- Result-oriented, proactive, ambitious, flexible, and creative
- Capable of working independently, yet actively participating in teamwork
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT, connecting talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.
Salary RangeThe full-time equivalent pay range for this position is $103,200.00 - $193,500.00/year, plus eligibility for bonus, stock, and benefits.
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