Regulatory Open Forum

Our Mission: PREAT Corporation is a team of dental professionals committed to providing the highest quality products, services, and expertise to our partners in order to improve the quality of life of all involved.

About Us: PREAT Corporation remains the only multi-generation family owned Precision Attachment Company. PREAT has no affiliation with any implant company.  We maintain a large well trained <g class="gr_ gr_207 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling" id="207" data-gr-id="207">technical</g> and customer service staff, including two ICOI Masters. We uniquely have the ability to provide both product and technical support for <g class="gr_ gr_208 gr-alert gr_spell gr_inline_cards gr_run_anim ContextualSpelling multiReplace" id="208" data-gr-id="208">35 year old</g> attachment cases as well as answer new treatment planning questions.

PREAT Corporation is committed to providing the latest technologies and products along with accurate, reliable and timely customer and technical service.

PREAT maintains constant ongoing product and technique development.

PREAT Corporation quality control systems are BS EN ISO 13485:2012, CE, and Health Canada certified.

Objective:

Assist with providing pre-market regulatory strategy and implementation to ensure regulatory approval objectives that support commercial initiatives for new and modified products. Assure that PREAT Corporation products comply with <g class="gr_ gr_212 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins replaceWithoutSep" id="212" data-gr-id="212">United</g> States and international medical device and import/export regulations. Correspond with governmental agencies and/or foreign distributors to determine product registration requirements and to provide evidence of compliance. Supports applicable regulations including Local, State, Federal and/or International requirements.

Duties:

• Coordinate the completion and submission of regulatory product files to result in timely and efficient registration of products (for initial registration of new products and market extension for current products)
• Manage submissions such as US FDA Section 510(k) Notifications, EU CE Technical Documentation, and global product registrations.
• <g class="gr_ gr_204 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins doubleReplace replaceWithoutSep" id="204" data-gr-id="204">Document</g>, consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies
• Participate in training and education seminars as appropriate to learn regulatory requirements and keep abreast of current regulatory trends.

Requirements

• Must have knowledge of U.S, Canadian, European and other International in Medical Device regulations and standards.
• Must be able to work well in a team environment with individuals from diverse functional areas, as well as independently manage work.
• Must have proven analytical capabilities, solid understanding of manufacturing processes, change control, regulatory principles <g class="gr_ gr_202 gr-alert gr_gramm gr_inline_cards gr_run_anim Punctuation only-ins replaceWithoutSep" id="202" data-gr-id="202">and</g> regulatory trends.

Skills:

• Highly developed written and verbal communication skills
• Working familiarity with statistical methods 
• Strong written, verbal communication skills and attention to details
• Strong working knowledge of MS Word, Excel, PowerPoint, Outlook

Benefits:

• Very competitive salary
• 401k Program
• Profit Sharing
• Company paid Anthem Blue Cross PPO
• Bonus Program
• Dental Reimbursement