Cyient Hiring Regulatory Affairs Associate | Pune

Cyient, a leading global engineering and technology solutions company, is currently hiring for the position of Regulatory Affairs Associate at their Pune office. This role offers a unique opportunity to work within the fast-paced and evolving field of medical device regulations. If you have a background in health sciences and regulatory affairs, particularly in the global medical devices sector, this could be the perfect opportunity for you.

Job Overview

As a Regulatory Affairs Associate at Cyient, you will play a key role in ensuring compliance with medical device regulations across various regions, including META, LATAM, APAC, EU MDR, and US 510(k)/PMA. The position is based in Pune, India, and offers the chance to work with international teams, navigate complex regulatory frameworks, and contribute to critical projects in the medical device industry.

Key Responsibilities

• 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.

Qualifications

To be considered for this role, candidates should meet the following qualifications:

• Education: A Bachelor’s degree or higher in a technical field, health sciences, or a related discipline.
• Regulatory Experience: Strong background in global medical device regulations, particularly with EU MDR, FDA, and country-specific regulations.
• Technical Expertise: Familiarity with medical device standards like EN IEC 60601, ISO 14971, and expertise in regulatory submissions for regions such as META, LATAM, and APAC.
• Communication Skills: Excellent verbal and written communication abilities, with a proven track record of collaborating with international teams.
• Additional Advantage: Proficiency in Portuguese and experience with Brazilian regulatory submissions would be highly desirable.

Desirable Skills

• Medical Device Standards
• EU MDD and ISO 14971 Risk Management
• IEC 62366 and 510(k) regulations
• Strong project management and people management skills

Location

This position is based in Pune, India,

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