Quality Officer

(Vacancy - 1)

Key Responsibilities:

1. Clinical Evaluation (CER):

Develop, review, and maintain Clinical Evaluation Plans and Reports (CEPs and CERs) in accordance with EU MDR, MEDDEV 2.7/1 Rev. 4 and MDCG guidance documents.

Conduct systematic literature reviews and clinical data analysis.

Ensure CERs are updated based on PMS findings, PMCF studies, and risk management files.

Liaise with cross-functional teams (clinical, design, risk management) to gather inputs.

2. Post-Market Surveillance (PMS):

Prepare and maintain PMS Plans, PMS Reports, and PMCF Plans/Reports.

Develop and update PSURs (Periodic Safety Update Reports) and Summaries of Safety and Clinical Performance (SSCPs).

Analyze complaint data, adverse events, and other real-world evidence to identify trends or emerging risks.

Coordinate vigilance reporting and Field Safety Corrective Actions (FSCAs)

3. Device Labelling & IFU Compliance:

Review and verify device labels and packaging artwork for regulatory compliance (EU MDR, FDA, ISO 15223-1, ISO 20417 and other relevant standard).

Ensure inclusion of correct symbols, warnings, contraindications, and UDI information.

Update and control Instructions for Use (IFUs) in line with CER, risk file, and usability findings.

Support labelling translations and country-specific labelling requirements.

4. CAPA (Corrective and Preventive Actions):

Lead or support the initiation, investigation, root cause analysis, and closure of CAPAs related to product quality or regulatory non-compliance.

Collaborate with Quality Assurance and Engineering to define corrective/preventive actions and verify effectiveness.

Monitor CAPA timelines and ensure documentation is maintained per ISO 13485 requirements.

Contribute to continuous improvement initiatives stemming from audit findings, PMS data, and internal reviews.

Qualifications:

Education:

Bachelor’s or Master’s degree in Biomedical Engineering, Life Sciences, Pharmacy, or equivalent discipline.

Experience:

3–6 years of experience in Regulatory Affairs or Quality Assurance in the medical device industry.

Hands-on experience with CERs, PMS activities, device labelling, and CAPA processes.

Knowledge of applicable regulations and standards: EU MDR 2017/745, ISO 13485, ISO 14971, MEDDEV 2.7/1 Rev.

Technical Skills:

Competence in literature search engines (e.g., PubMed, Embase) and root cause tools (e.g., Fishbone, 5 Whys).

Strong writing skills for technical documents and regulatory correspondence.

Key Attributes:

Detail-oriented and analytical.

Strong project and time management skills.

Collaborative mindset and excellent communication skills.

Ability to handle regulatory audits and respond to Notified Body queries.

Kindly share your resume to: connect@ifmedtech.com