Job Description

Description:

This position will be responsible for assisting the Regulatory Affairs initiatives and registrations/listings for all products for the US and EU markets.

The position will mostly support Class I Medical Device Products

Compile and maintain regulatory documentation databases or systems.

Coordinate efforts associated with the preparation of regulatory documents or submissions.

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

Coordinate, prepare, or review regulatory submissions for domestic or international projects.

Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.\xe2\x80\xa2 Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.

Participate in internal or external audits.

Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

Prepare or maintain technical files as necessary to obtain and sustain product approval.

Skills:

Regulatory Affairs, Medical Device, Regualtory Documents, FDA, EU MDR, Global Registration, Regulatory Submissions, cGMP, ISO 13485:2016, MDSAP

Top Skills Details:

Regulatory Affairs,Medical Device,Regualtory Documents

Additional Skills & Qualifications:

BS Degree Preferred - but not required

1-3 years of Regulatory Affairs experience in Medical Device

EU MDR experience would be 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.

Actalent