Regulatory Affairs Manager

Lawrence Harvey

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Job ID :

6098


Company Type :

Staffing Firms


Industry :

Medical and Nursing


Education Level :

Bsc


Address 1 :

North America,--California,Los Angeles,


Key Skills :

PMA IDE Class III


Salary :

Negotiable


Date Posted :

06 Feb, 2017



Company Name :

Lawrence Harvey


Location1 :

Los Angeles




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

Regulatory Affairs Manager

Industry: Medical Device

Location: Los Angeles



One of my key clients is currently looking for a Manager Regulatory Affairs based in their head office in LA.

As the Regulatory Affairs Manager, you will play a key role acting as the regulatory affairs subject matter expert for all applicable medical devices (class I, II & III). You will be responsible for identify, assessing and communicating the regulatory development and submission strategies, regulatory risks, interface with relevant regulatory authorities and review device aspects of all regulatory submissions.

Previous experience in developing strategies for regulatory approval (USA & OUS) for clinical and preclinical trials is ideal as you will be responsible for providing regulatory guidance to clinical Affairs, Quality Systems and Manufacturing & Development. As a result you will be responsible for preparing submissions, obtain and maintain their approval while ensuring all activities are carried out in compliance with all applicable laws and regulations.

The client is looking for someone with a strong technical & analytical background who is not scared to be hands on and therefore be able to exercise independent judgment in determining appropriate actions.

Must Have

* Minimum 5 years of Regulatory Affairs Experience with Class I, II & III medical Devices
* National & International Regulatory affairs Experience working with the FDA, EU & Health Canada
* Managed, prepared and submitted original IDEs, PMAs, HDEs, 510(k)s, documentation for CE Mark including technical files, and all applicable supplements and/or amendments
* Documented experience in producing related regulatory submissions (annual reports, change notifications, etc) and 510(K) letters to file to facilitate maintenance of approvals



If you think you have the appropriate experience and would be interested to hear more, please apply below or alternativly send me an email with a good time to call and your contact details.


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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