Regulatory Affairs Executive

3 months ago

Ahmedabad, India Royal Surgicare Pvt Ltd Full time

Industry: Class A & B Medical Devices

Qualification: Postgraduate or equivalent in Pharma/ Medical device Sector OR Biomedical Engineer

Experience: Min. 2 years in Certifications and Regulatory documentation

Reports to: Top Management

**Salary**: Commensurate with experience

About the role: An exciting opportunity in the field of Class A & B Medical devices Certification, QMS & Regulatory Compliances.

About Us:
We, ROYAL SURGICARE PVT. LTD manufacture & export an extensive range of any of medical devices for infusion therapy, transfusion therapy, gastroenterology, urology, anesthesia, cardiology and surgery at our high tech facility situated in Santej, Gandhinagar, Gujarat INDIA. In its drive to become the leading manufacturer & exporter in the field of Medical disposable, the company has developed quality and product System as per ISO 13485:2016.

Key responsibilities/ accountabilities:
Leading new products registration and license renewal in various countries

To Lead QA/RA team and ensure quality SOP’s within the company

Knowledge of ISO 13485 & Risk Management

Have the joint responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product life cycle, to accelerate and ensure successful product registrations and provides regulatory assessment and supports Change Control Assessment

Oversee maintenance of product quality and compliance through the Quality Assurance functions as well as management of the Quality Management System and compliance processes

Approve and verify implementation of defined systems, standards and procedures.

Ensure compliance of Change control procedures. & Ensure compliance of audits.

Carry out process controls, including in-process checks/inspections(all stages)/line clearances.

Investigate complaints, deviations, quality incidents and non-conformances.

Ensure implementation of amendments in specifications and procedures as per current applicable standards.

Review of SOPs, BMRs, specifications and change control to ensure compliance Support to validation activities

To investigate out of specification results or failure investigation related to testing or manufacturing etc.

Support Marketing/sales department for product review, product function training, catalogue preparation, content management, field queries resolution etc

Minimum 2 years of experience in technical documentation, regulatory affairs and quality assurance & QC in the medical device industry

Postgraduate or equivalent in Pharma/ Medical device Sector (Biomedical engineer preferred)

Ethical behavior and high level of integrity

Good teamwork, independent and committed to works across functional department

Possess good negotiation and dispute resolution skills

Ability to read, analyze and interpret governmental regulations & reports, scientific or clinical publications and data

Ability to write reports, business correspondence, and quality procedures

Must be able to effectively operate in a PC environment, be familiar with Microsoft Word, Excel, PowerPoint, Access, Outlook and Internet data search utilities

(Preferred local or ready to relocate)

You may please revert back to us with your complete resume and current & expected CTC

Office & Factory Address:
ROYAL SURGICARE PVT LTD

Plot No. 832, Near Ganesh Rubber,

Prima Automation Lane,

SANTEJ-382721.

Ta. Kalol, Dist. Gandhinagar

Gujarat (India)

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

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

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

**Experience**:

- Quality assurance (required)
- ISO 13485 (required)

**Speak with the employer**
+91 9773438663

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