Regulatory Affairs

5 days ago

Pune Maharashtra, India Kelly Services Internal Full time

**Job Title**:
Regulatory Affairs Engineer

**Locations**:
Pune, India

**Job Description**:

- **A Bachelor’s degree or higher in a technical field, health /Medical sciences or related.**:

- **Mandatory Background in the global medical devices Regulationindustry would be considered a strong plus.**:

- **Good knowledge on International regulation, META,LATAM,APAC,EU MDR,US 510 k/PMA**:

- **EU-MDR, FDA, Country Regulations, Design Change, Standards - EN IEC 60601 - 1 & 2, ISO 15223, ISO 14971, ISO 20417, EN IEC 62304 & EN IEC 62366.***:

- Extensive experience in RA international submissions, specifically within META, LATAM, and APAC regions.***:

- Proven ability to independently manage end-to-end activities and tasks.***:

- Strong verbal and written communication skills, with a track record of effective collaboration and follow-up with global teams.***:

- Demonstrated experience in handling health authority queries, including drafting and responding to queries.***:

- Proficient in good documentation practices and adaptable to changing situations.***:

- Expertise in using Windchill.***:

- Additionally, if we have some one with strongBrazil regulation experience along with local language - Portuguese that would be great**
- **Be able to handle changes in priority/planning.**:

- **Be able to determine best approach in process for project.**:

- **Be able to think from customer expectation perspective.**:

- **Be able to work in different teams simultaneously.**:

- **Communicative & disciplined team worker.**:

- **Affinity with technical writing.

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