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Regulatory Affairs Specialist 1-2 years experience in regulatory - medical device focus

Employer
Mosaic Regulatory Solutions
Location
East Midlands Region
Salary
Flexible
Start date
15 Sep 2022
Closing date
15 Oct 2022

View more

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

 

 

Role:Regulatory Affairs Specialist 6-12 months temporary role that will be made perm for right individual.

Medical Devices EMEA region 

Location - Home based or Hybrid with office in East Midlands

Salary - Flexible and Bonus , Holidays 

Duration - 6 to 12 months but the right person can be potentially made a permanent.

 

Focus of the role will be following:

 

Monitoring Registration Requirements within Region

           

  • Work with in-country representatives, contractors or perform independent research to determine regulatory requirements for product registrations in responsible regions Maintains up-to-date knowledge of regional and national regulations, guidelines, and advisory documents required for marketing products in a specified region. Communicate applicable regulatory requirements to  Regulatory Affairs management and business partners. Analyze impact and communicate to management changes in regulations or requirements that have been identified.

 

 

Regulatory Affairs Specialist

 

 

REPORTS TO

Lead Regulatory Affairs Specialist

 

 

 

POSITION SUMMARY

The mission of the International Regulatory Affairs function is to implement efficient and effective processes to initially obtain and then maintain clearance to market  products in support of global business plans. This includes determining registration and/or submission requirements in the International markets, working with international registration staff to identify requirements in other targeted markets, and working with product acquisition or development teams to ensure these requirements are met. This group also identifies and supports Regulatory Compliance needs.

 

The Regulatory Affairs Specialist will develop a firm working knowledge of the following market and the regulations and standards associated;

 

•               Europe/Middle East/Africa (EMEA)

o              European Union: Medical Device Directive 93/42/EC as amended by 2007/47/EC and Medical Device Regulation 2017/745

o              Regulations, standards and guidance documents necessary for a working knowledge in key EMEA countries such as Saudi Arabia, Israel, and Egypt

 

Key International Standards;

 

•               ISO 13485: Medical devices – Quality management systems

•               ISO 14971 Application of Risk Management to Medical Devices

 

The Regulatory Affairs Specialist will also develop a basic working knowledge of the U.S. FDA and the following;

 

•               21 CFR Part 820 – Medical Device Quality System Regulations (QSR)

 

The Regulatory Affairs Specialist will have responsibility for performing the duties of the functional areas described below, as assigned, under the guidance and direction of his/her manager and other senior Regulatory Affairs staff.

 

 

 

 

 

DUTIES

 

Registration Activity

 

  • Prepare, compile, and submit regulatory documents for the registration of current and new products in international markets. Maintain submission documents, shared drive folders, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information. Monitor pending submissions to ensure timely approvals.  Communicate to management any identified delays that may impact business expectations. Monitor approved registrations in respect to expiry and ensure management is aware of action required to renew in a timely manner to ensure no disruption in product distribution. Interact with Regulatory Affairs personnel at regulatory agencies, consultants, contract manufacturers, and distributors to ensure requirements are understood and submissions are complete and accurate to avoid any potential delays in approval.

 

Monitoring Registration Requirements within Region

           

  • Work with in-country representatives, contractors or perform independent research to determine regulatory requirements for product registrations in responsible regions Maintains up-to-date knowledge of regional and national regulations, guidelines, and advisory documents required for marketing  products in a specified region. Communicate applicable regulatory requirements to Regulatory Affairs management and business partners. Analyze impact and communicate to management changes in regulations or requirements that have been identified.

 

International Shipment Hold Report

 

  • Review the International Regulatory Status Tracking (IRST) report daily to monitor a specified region for activity not yet permitted or approved in a country. Investigate all unapproved activity on report to determine cause, work with RA staff to determine an appropriate strategy for hold release. General Duties Responsible for maintaining understanding of and compliance with all current active Corporate Procedures applicable to his/her job functions. Maintain conduct in accordance with the principles of the  Code of Business Conduct and comply with all Company policies. Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized. Conduct daily activities of assigned job responsibilities and projects as assigned. Support a safe, clean and secure working environment by supporting procedures, rules and regulations.

 

 

 

EDUCATION EXPERIENCE, KNOWLEDGE & SKILLS

 

 

 

 

 

 

 

 

 

 

 

    

 

  1. At least 2 years prior international regulatory experience is highly desired. Bachelors degree. With scientific, engineering, regulatory, quality or legal core competency. Masters degree desired, but not required. Bilingual skills desired, but not required.

 

In a numbered list, describe specific skills and/or business competencies:

  1. Self-starter that is highly organized.  Strong interpersonal skills – ability to work closely with people at all levels within the  organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officials. Strong oral and written communication skills. Excellent PC skills, including Microsoft Office applications. 

 

Company

Mosaic Regulatory Solutions is a specialist recruitment consultancy founded in 2002. Set up to meet the ever increasing demand for regulatory professionals in a market place with a growing skills gap.

Our expertise lies solely in regulatory affairs recruitment. And as such we have a real understanding of this sector. As this is our technical specialty we remain industry leading and preferred supplier of choice to a number of clients and first port of call for many regulatory affairs professionals.

We understand team / environmental “fit” is vital so continue to find the right career and environment to suit all candidates.

Listening to client needs, we respond with a professional, seamless and pro-active style of recruitment.

Mosaic work with an ever growing client base with the UK and Europe. We are dedicated to providing long term relationships with clients and candidates. We are proud that a high percentage of our business is repeat business.

Find Us
Website
Telephone
07951 082482
Location
Blackheath
London
SE3
GB
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