Orange County Regulatory Affairs Discussion Group (OCRA)
Specialist, Regulatory Affairs
Orange County Regulatory Affairs Discussion Group (OCRA), Irvine, California, United States, 92713
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.How you will make an impact:
As a Specialist, Regulatory Affairs for TMTT, you will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US and EU, focusing on the paradigm shifting transcatheter tricuspid valve replacement therapy.Responsibilities:
Preparing documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissionsRepresenting the regulatory function on manufacturing and product development teams to provide input on regulatory requirements.Strategizing and presenting alternatives for meeting regulatory requirements within regulatory affairs and cross-functionallyResolving conflicts between those requirements and development issuesAdvancing complex situations to management for guidance and training opportunitiesYou will prepare and oversee documentation packages for submission to global regulatory agenciesTracking timelines and documents milestone achievements for inclusion in regulatory submissions.You may interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files)Providing guidance on regulatory requirements necessary for contingency planningMonitoring proposed and current global regulations and guidance; assessing impact of such regulations and guidance on assigned project(s); proposing suggestions on utilizing regulatory updates to expedite approval processReviewing labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracyMinimum Requirements:
Master’s degree and previous related experience
OR
Bachelor’s degree and 3 years of previous related experienceCoursework, seminars and/or other formal government and/or trade association trainingPreferred Qualifications:
Master’s degree in scientific discipline and 1 year of preparing (writing) domestic and international submissionsBachelor’s degree in scientific discipline and 3 years preparing (writing) domestic and international submissionsSolid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class IIISolid knowledge of global regulatory requirements for new products or product changesSolid knowledge of new product development systemsAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $70,000 to $100,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
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As a Specialist, Regulatory Affairs for TMTT, you will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US and EU, focusing on the paradigm shifting transcatheter tricuspid valve replacement therapy.Responsibilities:
Preparing documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissionsRepresenting the regulatory function on manufacturing and product development teams to provide input on regulatory requirements.Strategizing and presenting alternatives for meeting regulatory requirements within regulatory affairs and cross-functionallyResolving conflicts between those requirements and development issuesAdvancing complex situations to management for guidance and training opportunitiesYou will prepare and oversee documentation packages for submission to global regulatory agenciesTracking timelines and documents milestone achievements for inclusion in regulatory submissions.You may interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files)Providing guidance on regulatory requirements necessary for contingency planningMonitoring proposed and current global regulations and guidance; assessing impact of such regulations and guidance on assigned project(s); proposing suggestions on utilizing regulatory updates to expedite approval processReviewing labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracyMinimum Requirements:
Master’s degree and previous related experience
OR
Bachelor’s degree and 3 years of previous related experienceCoursework, seminars and/or other formal government and/or trade association trainingPreferred Qualifications:
Master’s degree in scientific discipline and 1 year of preparing (writing) domestic and international submissionsBachelor’s degree in scientific discipline and 3 years preparing (writing) domestic and international submissionsSolid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class IIISolid knowledge of global regulatory requirements for new products or product changesSolid knowledge of new product development systemsAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $70,000 to $100,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
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