Associate Regulatory Affairs Specialist

 
Location: North Haven, Connecticut
Posted On: 4/11/2017
Job Code: ARAS_CT2128
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Job Description
 
Description SUMMARY OF POSITION:
The Regulatory Affairs Associate is responsible for assistance with management of the Regulatory Affairs department activities, supporting US FDA and EU submissions and the support in managing international regulatory registrations with the Regional Business Units (RBU), which includes global regulatory strategies and impact assessments, initial registrations, re-registrations and notifications/registrations of changes that may impact the regulatory approvals.
ESSENTIAL FUNCTIONS:
Collaborate and support RBUs to determine local regulatory pathways, requirements and timelines.
Collaborate and support RBUs by providing the documentation necessary to prepare their local regulatory submissions. Including, but not limited to obtaining Certificates to Foreign Government, Letter of Authorization, technical reports, and the notarization of documents.
Collaborate and support RBUs in coordinating international regulatory activities on behalf of the Surgical Innovations business.
Ensure the timely and accurate filing of regulatory documentation.
Develop and maintain product technical files.
Maintain product licenses by providing annual notifications as required by specific regions.
Assist in the development, documentation, and implementation of regulatory strategies for product modifications and manufacturing production line transfers to include applicable international requirements.
Provide regulatory affairs support to design and change control teams to assess regulatory impact of design changes including and manufacturing production line transfers.
Actively maintains and reports registration status with applicable registration trackers and applications.
Perform other regulatory affairs duties when requested.
Interface with quality, operations, clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities.
Ensures rapid and timely responses to requests from regulatory agencies and third party registrars Education required:
Bachelor’s degree in a scientific or engineering field Experience
2+ years related experience in a technical job function/role
Preferred Skills/Qualifications:
Experience in a regulated industry, preferably medical devices, with an emphasis in regulatory or quality assurance
Excellent verbal and written communication skills
Experience using electronic filing systems, and/or databases
Ability to interface effectively with individuals from a wide variety of disciplines to research and obtain appropriate documentation for the submission of regulatory information.
Ability to prepare and submit regulatory documentation packages.
Have the basic knowledgeable with international regulations
Ability to interface effectively with international individuals to support global registrations Skills/Competencies:
High Level of proficiency using MS Excel and MS Word.
Working knowledge of MS Access, MS Project, MS InfoPath and Adobe Acrobat Pro.
High learning aptitude and adaptability with software systems
Demonstrated technical writing skills
Category:Non-IT  code:new
 
 
Job Requirements
 
 
Engineering, Management, Marketing, MS Access, MS Excel, MS Project, MS Word, Quality Assurance, Research
 

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Contact Details
 
Recruiter
Ebrahim Sayarwala
 
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