Technical Lead

About Wipro

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients' most complex digital transformation needs.

We leverage our holistic portfolio of capabilities in consulting, design, engineering, operations, and emerging technologies to help clients realize their boldest ambitions and build future-ready, sustainable businesses.

A company recognized globally for its comprehensive portfolio of services, strong commitment to sustainability and good corporate citizenship, we have over 250,000 dedicated employees serving clients across 66 countries.

We deliver on the promise of helping our customers, colleagues, and communities thrive in an ever-changing world.

• A PROUD HISTORY OF OVER 75 YEARS
• FY22 REVENUE 10.4 BN USD
• WE'RE PRESENT IN 66 COUNTRIES
• OVER 1,400 ACTIVE GLOBAL CLIENTS

Role

Regulatory Affairs lead

Key Skills

DHF remediation,Test Method Validation,MSA,Risk Management,EUMRD Labelling,Redline Creation,CE Marking,ISO 15223, ISO 60601-1

Location

Minneapolis. Minnesota

Roles & Qualifications

Seeking a Regulatory Affairs professional with global/MDR or MDD (Medical Device Directive) labeling experience• Experience with CE Marking and European Union Medical Device Regulations ( EU MDR)• Experience with Redlining medical device product labeling to country requirements• Development of labeling requirement specifications, requirements traceability• Subject matter expert in MDD/MDR product labeling• Command of labeling standards such as ISO 15223, ISO 60601-1

What are your top three to five soft skill wants?

• An active listener with strong verbal and written communication skills• Negotiation skills• Requires Problem-solving skills for creative thinking to find solutions and have the ability to make sounds risk based decisions• High level of business acumen• Ability to identify and communicate potential compliance issues and escalate as necessary.• Self-starter with strong time management skills

Wipro is an Equal Employment Opportunity employer and makes all employment and employment-related decisions without regard to a person's race, sex, national origin, ancestry, disability, sexual orientation, or any other status protected by applicable law.

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