Sr. Regulatory Affairs Specialist

Medtronic

7 - 12 years

12 - 17 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

surgical project management artificial intelligence pharma agile manager technology healthcare information management regulatory affairs robotics

Work Mode

Work from Office

Job Type

Full Time

Job Description

Day in the Life

Responsibilities include but are not limited to the following:

Owner of multiple Regulatory processes Regulatory Information Management System, Global Item Create (GIC), Tender requests.
Data Steward of RIMS, GIC, tenders ensures accuracy of data.
Liason with OU Regulatory to ensure accurate application of processes and assignment of data attributes
Reporting of regulatory data/ metrics.
Conversion of Technical Documents to Global Submission Summary Documentation (GSSD).
Creation of e-BOM structure in CAP Agile for GSSD.
Streamline Processes through use of Artificial Intelligence.
Monitors and remains in compliance with multiple Quality Management Systems.
Keeps abreast of regulatory procedures and changes.

Must Have: Minimum Requirements

Bachelor s degree in Medical, Mechanical, Life Science or other healthcare related major.
7+ years experiences for RA role in medical device and or pharmaceutical industry.
Works independently with general supervision on larger, moderately complex projects / assignments.
Contributes to the completion of project milestones.
Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues to inform, gain input, and support decision making.
Flexible working hours Times will be required to be work in US EST time zone.

Nice to Have

US and global regulatory affairs knowledge and experience.
Experience working with cross-functional teams.
Effective verbal and written communication skills both internally and externally.
Experience with solving problems and concerns.
Experience with project management and adherence to time schedules.
Work well under pressure in a dynamic environment.
Highly organized, detail-oriented, and efficient.
Team player who seeks to help and learn from colleagues seeing the department success as their own
Ability to manage projects to completion within and outside of the direct department and company.
Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
Proactively seeks to develop and become well-versed within the regulatory landscape.
RAPS Regulatory Affairs Certification (RAC).

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