Senior Regulatory Affairs Specialist

United Kingdom
72639.00 - 80710.00 GBP Annual + GBP72639 - GBP80710/annum
10 Feb 2017
24 Feb 2017
Contract Type
Full Time
Job Title: Senior Regulatory Affairs Specialist
Business Area: Medical Devices
Location: Florida
Salary: $90k - $100k

Job Description:
Hamilton Mayer is working with a leading Medical Device company specialising in Orthopedics, that currently has over 3,500 employees worldwide. The company is seeking a Senior Regulatory Affairs Specialist, to provide regulatory input for new product and sustaining engineering project teams and develops a regulatory strategy for global commercialization of products.

Key Responsibilities:
*Represent the Regulatory organization on cross functional teams to develop and implement regulatory strategies and carry out associated team output responsibilities.
*Prepare global regulatory files / submissions for product registrations as assigned.
*Review and approve proposed design changes and ECOs to assess regulatory impact.
*Work collaboratively with other RA staff to ensure consistency of RA inputs and strategies.
*Provide regulatory support for on-going global product registrations as assigned.
*Provide timely review and approval of product labelling for regulatory compliance Interfaces with other business units/affiliates/distributors as assigned.
*Perform other related duties and special projects as required by management.
*Performs other duties and special projects as assigned.

Requirements & Experience:
*Minimum five years in a regulatory position.
*Bachelor's degree in science, engineering or related field required.
*Experience in multiple 510(k) submissions.
*Ability to execute assignments independently as assigned.
*Must possess strong organizational skills.
*Must possess strong written and verbal communication skills.
*Must possess demonstrated ability to handle multiple priorities simultaneously.
*Proficient on Microsoft Office products.

About Hamilton Mayer International
Hamilton Mayer International is a leading executive search and selection business. From our offices in Leeds we provide retained and contingency recruitment solutions across various industry sectors and have specialist recruitment consultants that work within the Transportation, Rail, Utilities, Building, Property, Residential Development, Chemicals & Coatings and Medical/Life Sciences market