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Job: Senior Regulatory Affairs Officer

Job Title: Senior Regulatory Affairs Officer
Contract Type: Permanent
Location: West Midlands
Sector:
Salary: Competitive salary in line with experience
Start Date: 2018-05-22
REF: SRAOCREAVO
Contact Name: Tanya Zero
Job Published: 3 months ago

Job Description

A phenomenal opportunity has arisen at a diagnostic technology manufacturer in the West Midlands for a Regulatory professional. This British owned company take huge pride in their products. They are accredited to ISO 13485 and also have FDA 510(k) clearance and their products are award-winning! The business is full of medical professionals wanting to make a difference. They are looking for like-minded individuals to join the team and join their Regulatory department as a Senior Regulatory Affairs Officer.

 

In this role, you will be focusing on day to day regulatory compliance requirements for the businesses product portfolio. You will provide support to various departments to ensure compliance is company-wide. Product registrations will be a key aspect of your role as will supporting risk management activities and technical file preparation. You will be encouraged to develop strong working relationships with both internal and external clients and will be keeping up with the latest regulatory changes and monitoring potential impacts this may have on the business.

 

Key knowledge/Experience includes...

 

-  Experience of Medical Device Directive 93/42/EEC and the Medical Device Regulation MDR 2017/745 and relevant technical files.

 

-  Experience in working towards ISO 14971 and ISO 13485:2016.

 

-  Knowledge/experience working within a GMP environment

 

-  Experience with 21 CFR 820 requirements would be advantageous.

 

To apply please send your CV to tanya.z.a4lglnnzwnf@monarch.aptrack.co.ukering and if you are successful we will contact you within 7 days.

 

We are an equal opportunity employer and value diversity at our company.We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.