Boston Scientific
Regulatory Affairs Specialist II
Boston Scientific, Saint Paul, Minnesota, United States, 55112
Regulatory Affairs Specialist II
Work mode: Hybrid Onsite Location(s): Arden Hills, MN, US, 55112 At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing
whatever your ambitions. About this role: As a part of the Boston Scientific Cardiac Rhythm Management division, you will work to deliver advanced, life-saving and sustaining technologies to patients worldwide. We provide innovative solutions for diagnosing and treating heart conditions, and we're constantly advancing in crucial areas and expanding our reach into new markets and regions. In this role, you will be encouraged to be curious, develop and employ creative and critical thinking skills, and will have the opportunity to satisfy your desire to learn about emerging technologies and their impact on the business and organization. Joining the Cardiac Rhythm Management (CRM) Regulatory team at Boston Scientific means you'll play a pivotal role in delivering cutting-edge technologies that preserve and save lives across the globe. Your responsibilities will include: Supporting the development of global strategies for regulatory approval of Class I, II and III medical devices Coordinating, compiling, and submitting U.S. and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR Assisting with BSC International regulatory requests regarding submissions, registrations, and change assessments; develop and manage relationships with regulatory representatives Reviewing product and manufacturing changes to ensure compliance with applicable regulations and impact on regulatory filings Supporting regulatory audits as needed Reviewing promotional materials for regulatory compliance Representing Regulatory Affairs on cross-functional projects such as product development, manufacturing process changes, and continuous improvement Assisting with departmental projects such as procedure stewardship, Value Improvement Projects (VIP), and Regulatory Operations initiatives Keeping abreast of emerging technologies and potential business and organizational impacts Working with clinical affairs on various aspects of clinical trials and clinical reports Required Qualifications: Bachelor's degree in life science, engineering or related disciplines 2+ years regulatory or related experience Technical writing skills Preferred Qualifications: Working knowledge of regulatory requirements for medical devices Effective written and oral communication skills Strong computer skills with experience using Adobe Acrobat and Microsoft Office applications (Word, Excel, PowerPoint, etc.) Experience working with cross-functional teams Relevant coursework, work-study, or internship experience with US, EU, and international regulatory requirements for medical devices and quality systems standards Ability to work effectively as an individual and as part of a team; ability to recognize and consider varying perspectives Experience working directly with US FDA, notified bodies and/or international health authorities Demonstrated ability to effectively lead multiple projects and priorities Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Work mode: Hybrid Onsite Location(s): Arden Hills, MN, US, 55112 At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing
whatever your ambitions. About this role: As a part of the Boston Scientific Cardiac Rhythm Management division, you will work to deliver advanced, life-saving and sustaining technologies to patients worldwide. We provide innovative solutions for diagnosing and treating heart conditions, and we're constantly advancing in crucial areas and expanding our reach into new markets and regions. In this role, you will be encouraged to be curious, develop and employ creative and critical thinking skills, and will have the opportunity to satisfy your desire to learn about emerging technologies and their impact on the business and organization. Joining the Cardiac Rhythm Management (CRM) Regulatory team at Boston Scientific means you'll play a pivotal role in delivering cutting-edge technologies that preserve and save lives across the globe. Your responsibilities will include: Supporting the development of global strategies for regulatory approval of Class I, II and III medical devices Coordinating, compiling, and submitting U.S. and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR Assisting with BSC International regulatory requests regarding submissions, registrations, and change assessments; develop and manage relationships with regulatory representatives Reviewing product and manufacturing changes to ensure compliance with applicable regulations and impact on regulatory filings Supporting regulatory audits as needed Reviewing promotional materials for regulatory compliance Representing Regulatory Affairs on cross-functional projects such as product development, manufacturing process changes, and continuous improvement Assisting with departmental projects such as procedure stewardship, Value Improvement Projects (VIP), and Regulatory Operations initiatives Keeping abreast of emerging technologies and potential business and organizational impacts Working with clinical affairs on various aspects of clinical trials and clinical reports Required Qualifications: Bachelor's degree in life science, engineering or related disciplines 2+ years regulatory or related experience Technical writing skills Preferred Qualifications: Working knowledge of regulatory requirements for medical devices Effective written and oral communication skills Strong computer skills with experience using Adobe Acrobat and Microsoft Office applications (Word, Excel, PowerPoint, etc.) Experience working with cross-functional teams Relevant coursework, work-study, or internship experience with US, EU, and international regulatory requirements for medical devices and quality systems standards Ability to work effectively as an individual and as part of a team; ability to recognize and consider varying perspectives Experience working directly with US FDA, notified bodies and/or international health authorities Demonstrated ability to effectively lead multiple projects and priorities Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.