Position Description

The Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for developing regulatory strategy, preparing U.S. and EU submissions and obtaining approval to ensure the continued regulatory compliance of existing \ products and therapies on markets worldwide. The roles focuses on regulatory support for the US and EU markets, as the RAS reviews product/manufacturing process changes, supplier changes, new and revised engineering protocols and reports, and product labeling, and determines the impact on existing approvals. 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. From developing and authoring regulatory submissions to providing critical input on cross-functional project teams and developing regulatory strategy, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the world’s leading medical device company.

POSITION RESPONSIBLITIES:

• Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for on-market products.

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

• 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.

• Review product changes

• Manages submission activities for a variety of device regulatory approvals including the CE mark change notifications, US PMA supplements, 510(k)s, post-approval reports, annual reports, 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.

MINIMUM REQUIRED QUALIFICATIONS:

• Bachelor's Degree in chemistry, scientific or engineering discipline

• 4+ years of work experience in engineering within the medical device industry with Bachelor’s Degree in medical device, biotech, or pharmaceutical industry

• 2+ years of work experience in engineering within the medical device industry with Master’s Degree in medical device, biotech, or pharmaceutical industry Desired/Preferred Qualifications

• History of successful 510(k)/IDE/PMA device/supplement submissions and other worldwide submissions and clearances.

• 2+ years of experience in healthcare industry (i.e. medical device,IVD pharma/drugs, biologics, biotech)

• Expertise in 30-Day Notices and RTRs, Design Dossiers, and Technical Files

• 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.

• Regulatory Affairs Certification (RAC)