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Principal Regulatory Affairs Specialist


This is a Full-time position in Atlanta, GA posted March 31, 2021.

Principal Regulatory Affairs Specialist (6 month contract // Remote, team based in Southern CA ): nn HM”s Top Needs:nn 1.

Regulatory Affairs Experiencenn 2.

Hardware/Software Experience for Medical Devicesnn 3.

Detail Orientednn nn Will consider candidates working fully remote anywhere in the US.nn nn The Principal Regulatory Affairs Specialist (Pr.

RAS) is responsible for developing regulatory strategy, preparing U.S.

and EU submissions and obtaining approval to introduce new Medtronic products and therapies to markets worldwide.nn nn The Pr.

RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required.

Primary responsibilities include: developing global regulatory strategies; preparing US, EU and international regulatory submissions; providing documentation for international submissions; supporting post-market regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables.nn This role focuses on regulatory support for the US, EU, and Global markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your RA skill set every day.

In this role, you will have primary RA responsibility for multiple Class II and Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.nn From developing and authoring regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the worlds leading medical device company.nn nn Position Responsibilitiesnn Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for new products.

Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

Prepare FDA submissions and CE Mark Technical Files for product changes and/or new products as required to ensure timely approvals for market released products.

Provide support to currently-marketed products as necessary.

This includes reviewing product changes and documentation for changes requiring government approval.

Prepare submissions and reports for FDA and support other international agencies as required by product status.

Manages submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, Q-subs, IDEs, export certificates, and establishment registrations and device listings.

May interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level.

All significant issues will be reviewed with the manager.

Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.

Ensure personal understanding of all quality policy/system items that are personally applicable.

Follow all work/quality procedures to ensure quality system compliance and high-quality work.

nn Must Have: Minimum Requirements (Must be evident on the resume) Years of Experience:nn 7+ years of regulatory experience in medical device, biotech, or pharmaceutical industry with Bachelors degree.

5+ years of regulatory experience in medical device, biotech, or pharmaceutical industry with Masters degree.

Experience in regulatory submissions (i.e.

writing/developing/preparing/creating submission for medical devices (PMA, 510(k)), Investigational Device Exemption (IDE), EU technical files for Class IIa/IIb and design dossiers for Class III, medical device or drug submissions) nn Education Required:nn Engineering or scientific discipline, such as biology, chemistry or physics Regulatory Science n n Job Requirements: n Desired/Preferred Qualificationsnn History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.

Expertise in IDEs, PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files,30 day Notices, and Real Time Reviews Experience with regulatory support of clinical trials Experience in assembling facts from various areas, analyzing data, and providing informed recommendations Product experience with Radio Frequency (RF), Electromagnetic Compatibility (EMC), Software and Implantable devices and thorough knowledge of regulatory requirements Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reports.

IVD device experience is preferred.

Regulatory Affairs Certification (RAC) Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting Must be able to write clear, understandable technical documents, i.e.

regulatory documentation or scientific presentations.

Ability to compile data and summarize results Organized, efficient, process-oriented; high attention to detail Effective interpersonal/communication skills Works well under pressure in a dynamic timeline-driven environment Ability to effectively manage multiple projects and priorities Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills Support regulatory compliance and submissions Filing documents related to regulatory submissions Ensure compliance to existing regulatory submissions Preparing regulatory documents and/or submissions Submit regulatory applications and internal regulatory file documentation Verify compliance with regulatory requirements Ensure compliance with regulatory requirements Assure compliance of regulatory files Providing regulatory and compliance guidance Prepare submissions and reports for regulatory agencies Ensure compliance to regulatory standards Support and ensure regulatory compliance Discuss regulatory issues and submission requirements Formulate or implement regulatory affairs policies and procedures to ensure regulatory compliance Assisting regulatory team in developing regulatory strategy to ensure high quality and on-time regulatory submissions Maintain regulatory r

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