Description:

Day to Day: This role will be creating technical documents under the In-Vitro Diagnostic in Europe - very similar submissions to PMA, 510k, or BLA. Responsible for registering IVDR products over their 3 month contract to catch the departments products up to date...

Responsible for coordinating preparation, review and submission of product applications 510(k), BLA, or their equivalent in foreign markets. Will coordinate development of responses to deficiencies and/or questions related to regulatory submissions. Additionally, will review and approve quality system documents to determine compliance with SOPs, quality system and regulatory requirements, and industry standards.

Additional responsibilities include:

• Supporting regulatory submissions for modified In-Vitro Diagnostic products and biologics

• Reviewing and approving significant changes (e.g. facility, product, process and labeling changes) for regulatory impact and domestic and international reporting requirements

• Developing regulatory strategies for implementation

• Maintaining regulatory product files of information submitted in support of domestic and international registrations

• Coordinating field action and vigilance activities for product lines and notifying appropriate regulatory agencies, affiliates and distributors

• Performing tasks and functions associated with product recalls/field corrections including preparing customer notifications, government submissions, status reports and recall effectiveness checks

• Evaluating complaint and internal deviation report data to determine the need for Medical Device Reporting, field action, or Biological Product Deviation reporting

• Maintaining compliance with Medical Device Listing requirements for products

• Recognizing and elevating critical regulatory/compliance issues to Regulatory Affairs management

• Writing and maintaining departmental SOPs

• Developing and tracking quality metrics related to Regulatory Affairs department

• Assisting with the administration of regulatory and third-party inspections

Skills:

IVDR, Medical device, Regulatory submission, Regulatory affairs, In-Vitro Diagnostic, Regulatory, IVD, EUMDR, Fda, Pma, 510k, IND, CBER, BLA, iso standards, class c

Top Skills Details:

IVDR,Medical device,Regulatory submission,Regulatory affairs,In-Vitro Diagnostic,Regulatory,IVD

Additional Skills & Qualifications:

Ideal candidate has previous experience working as a Senior Regulatory Affairs Specialist or Regulatory Affairs Manager

The best candidate has 5 years experience and is, a quick learner, able to problem solve, resourceful and can work independently

Previous experience creating technical documentation for regulated products.

Experience registering Class 2 or 3 medical devices - Knowledge of Class C medical devices would be prefer

Previous experience with bench testing and scientific knowledge is preferred but not required

Education - associates degree, preference in science space

Post market experience

Knowledge of relevant FDA and Health Canada regulations, IVDR, and ISO standards

Proficiency in MS Office products

Experience with IVD devices regulated by CBER, preferred

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law
Peachtree Corners GA USA

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