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Regulatory Affairs Specialist

Employer
i-Pharm Consulting
Location
Homeworking
Salary
USD90000 - USD110000 per annum
Start date
12 Aug 2022
Closing date
26 Aug 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

I have the opportunity to work a Regulatory Affairs Specialist position for a well funded medical device start-up company based in Southern California. Within this opportunity you will be responsible for the labeling, registrations, submissions, and UDI for an implantable spinal company that is going to change the way surgeons operate.

This company is focused on utilising a combination of Artifical intelligence, Imaging, and machine learning to create a patient-centric, more accessible, and personalised product in the medical device industry.

What this opportunity has to offer:

- Fully remote and full-time

- Personal manager/team

- 401k plus match

- A CEO who supports, understands,and values the importance of regulatory affairs

- Salary range from $90k-$110k

What you will need:

- 3-5 years of medical device regulatory affairs experience

- US FDA experience

- Bachelor's degree in science, engineering or related field

- Experience with pre-market submissions, post-market activities, registration, and listing

- Experience in or desire to learn 510(k) writing

- Ability to multi-task in a start-up environment

- Excellent written and verbal communication

What you will do:

- Coordinate and submit 510(k) applications while managing timelines

- Develop, manage and communicate UDI requirements. Manage FDA GUDID.

- Manage product labeling, including product labels, IFU and Surgical Technique updates.

- Organize and maintain regulatory files, including submissions, communications and other data.

- Participate in third party regulatory audits

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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