Regulatory Affairs Executive

15 hours ago

Ahmedabad Gujarat, India Angiplast Private Limited Full time

“Job Description”

**Position**:Regulatory Affairs - Executive Cum Microbiologist**

**Department: Regulatory Affairs / Microbiologist**

**Min Qualification: B.Pharm, M.pharm,Bio-Medical Engineer, B.Sc or M.sc with Microbiology**

**Min Experience: 3 - 5 Years**

**SAARY**: 30,000 To 60,000

**Industries Preferred: Medical Device / Pharma / Bio-Tech / Healthcare**

**Location: Preferred Ahmedabad**

**Responsibilities for Regulatory Affairs - Executive Cum Microbiologist**

Knowledge of ISO 9001, ISO 13485, CE, US-FDA (510K), Other Regulatory & CDSCO Guidelines.

Planning, review and submission of Documents as per Country Specific regulatory guideline in medical device registration.

Prepare and maintain technical file and medical device master files as necessary to obtain and sustain product approval.

Keeping records to documents and samples of different Countries.

Co-Ordination with respective departments for Regulatory requirements such as documents (Quality Analysis report, Comparative study report, Validation protocols and Reports, New product Documents, Samples and Reference Standards etc.)

Clinical investigation, Risk Management etc.

Keeping country specific records & Dossiers sample.

Responsible for resolving product registration queries as per required.

Should be able to get involve in External & Internal Audits conducted by various notified bodies & specific country FDA.

Responsible to guide the organization with the new regulatory guidelines.

Provide the updated knowledge relevant to regulatory guidelines, Literature.

Sterility Test, Bioburden, LAL Test & record updating.

Clean Room Environment Monitoring

Water testing.

Coordination with QA HOD reg. training, OOS investigation, audit.

Extend the support of regulatory affairs in preparing the analytical data as the requirement of product registration at different countries.

Ensure compliance of cGMP practices & preparation of SOPs.

Microbiological testing of samples & microbiological testing of RM/PM/FP & in process sample.

Media preparation, sterilization & testing & discard with documentation.

Culture handling & maintenance.

Validations pertaining to microbiological lab.

Validation of sterilization process & equipment’s.

IQ/OQ/PQ of lab equipment’s.

Trendy of data.

**Company Profile**:
**Angiplast Private Limited**

Angiplast is manufacturing Medical Disposables for 20 years having ISO 13485, CE certificate on manufacturing Class 1 and Class 2 devices. Company is also registered with USFDA and has USFDA 510k for several Products. More than 75% of the production is exported. The company is growing at CAGR 20 % and has aggressive expansion plans.

**Job Types**: Full-time, Regular / Permanent

**Salary**: ₹30,000.00 - ₹60,000.00 per month

**Benefits**:

- Leave encashment
- Provident Fund

Schedule:

- Morning shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

- Ahmedabad, Ahmedabad - 382445, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 3 years (preferred)

**Speak with the employer**
+91 6357091162

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