Regulatory Affairs Specialist
Company: Rangam Consultants Inc.
Location: Santa Clara
Posted on: January 25, 2023
I am ok with 2 years but it has to be in medical devices RA (not
quality, not IVD, not drugs)
Otherwise 3-5 years experience may be more likely appropriate
- Looking for someone with 2+ years exp specifically
international intermissions or writing they will be working on over
100 country submissions.
- Prefer regulatory background with medical device
- Quality systems
- Tech files work
- Complex product
- They work on drug eluding stents documentation
- Regulatory and technical knowledge
- Be able to follow proceduresDuties:
- This position will be working with multiple business units to
develop, update, and improve regulatory affair processes.
- Assist the strategy implementation and operations for
regulatory affairs activities, including directing development of
product registration submission, progress reports, supplements,
amendments, or periodic experience reports.
- Update and develop procedures for the regulatory affairs in
supporting changes in the regulatory landscape, including EU MDR.
Identify opportunity for regulatory affair processes and drive
changes to completion.Other skills:
- Good communication skills working with international sites
- Break down questions and discussion in detail
- Prioritize what the ask is and workload they have
- Learn quickly and understand details
- Thinking strategically plan ahead
- Asking questions.Preferred:
- Change management experience, international registrations and
- Must have excellent communication skills and follow up.
- Must know how to use Microsoft Outlook, Excel, Word and
- From a perspective of soft skills
- looking for someone who can work independently with direction
and is able to project plan.
- They need to be doers and enthusiastic about the job.
background in Class 3 medical devices is a plus good communicator
and should be proficient at able to use microsoft office, excel and
- Must have 3-5 years of experiences in Medical Device Regulatory
- Have working knowledge in EU MDR
- Have working knowledge in Regulatory Change Assessment in
- Have working knowledge in US and EU medical device
- Have experience supporting internal and external
- Work cross-functionally and in a matrixed environment
- Have experience with continuous improvement
- BA Degree Required
Rangam Consultants is a minority, women-owned, disability workforce
solutions global organization. Specialized in attracting and
retaining talents globally for a rewarding career in IT,
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Keywords: Rangam Consultants Inc., Santa Clara , Regulatory Affairs Specialist, Other , Santa Clara, California
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