["Principal Regulatory Affairs Specialist - Advertising & Promotion","Principal Regulatory Affairs Specialist - Advertising & Promotion"] Boston Scientific["Principal Regulatory Affairs Specialist - Advertising & Promotion","Principal Regulatory Affairs Specialist - Advertising & Promotion"]Saint PaulWork mode: Hybrid Onsite Location(s): Arden Hills, MN, US, 55112 Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance 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. Minimum of 5 years' experience in marketing, labeling, training, Regulatory Affairs, or related compliance roles within the medical device industry, including review of advertising, promotional, sales, and training materials.
["Regulatory Affairs Specialist","Regulatory Affairs Specialist"] Insight Global["Regulatory Affairs Specialist","Regulatory Affairs Specialist"]Saint PaulMaintain positive communications with division graphic coordinators, marketing brand managers, global specification team and R&D regarding program requirements. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.
Regulatory Affairs Specialist Teleflex IncRegulatory Affairs SpecialistMaple Grove, MN$88,000–$130,000 / yearMust possess a basic understanding of product risk/benefit concepts, working knowledge of US and International regulations applicable to market authorization for Vascular products, good verbal communication, technical writing, intra- and interdepartmental communication, and collaboration skills. The pay range for this position at commencement of employment is expected to be between $88,000.00 - $130,000.00; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistPlymouth, MN$99,000–$157,000 / yearThe actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.
Regulatory Affairs Specialist II Stereotaxis IncRegulatory Affairs Specialist IIMinneapolis, MNPosition Summary: The Regulatory Affairs Specialist II provides hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements/strategies and preparation of submissions. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information.
Advanced Regulatory Affairs Specialist Bio-TechneAdvanced Regulatory Affairs SpecialistMinneapolis, MN$62,300–$102,350 / yearThis position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). Why Join Bio-Techne: We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
Regulatory Affairs Specialist Talent Software Services, Inc.Regulatory Affairs SpecialistMaple Grove, MN$50–$55 / hourThe ideal candidate will possess deep knowledge of U.S. and international medical device regulations, strong analytical capabilities, and the ability to collaborate effectively across cross-functional teams to drive compliance and continuous improvement initiatives. This role is responsible for ensuring compliance with global regulatory requirements related to product incident reporting, corrective and preventive actions (CAPA), recalls, field actions, audits, and post-market surveillance activities.
International Regulatory Affairs Specialist Mclaughlin Gormley KingInternational Regulatory Affairs SpecialistBrooklyn Park, Minnesota$90,000–$100,000 / yearMGK has 100+ years' of experience focusing on sustainable & environmentally conscious ways to protect families and crops from pests around the world, using our synthetic and certified organic, botanically based pesticide products. This role requires close collaboration with sales and marketing to support compliant product strategies and effectively prioritize and manage related projects.
Regulatory Affairs Specialist I Laborie Medical Technologies CorpRegulatory Affairs Specialist IMinnetonka, MinnesotaThe individual will contribute to regulatory strategy and execution for assigned product lines, including preparing and submitting regulatory submissions, managing product registrations and renewals, and ensuring ongoing compliance with global regulatory requirements. Defining worldwide regulatory requirements necessary for regulatory approval of assigned products, and advising cross-functional teams on regulatory strategies.
Principal Regulatory Affairs Specialist Elucent MedicalPrincipal Regulatory Affairs SpecialistEden Prairie, MinnesotaThe Principal Regulatory Affairs Specialist independently performs regulatory impact assessments for product design, manufacturing, labeling, software, process, supplier, and site changes; prepares technical documentation and regulatory submissions; supports implementation of regulatory pathways and strategies established by the Regulatory Affairs Director; and provides regulatory analysis to support product development, commercialization, change control, and post-market activities. Required: direct, hands-on experience preparing and supporting FDA 510(k)s for medical devices, including substantial equivalence documentation, submission compilation, FDA question responses, and clearance support.
Principal Regulatory Affairs Specialist Elucent Medical IncPrincipal Regulatory Affairs SpecialistEden Prairie, MN$120,000–$135,000 / yearThe Principal Regulatory Affairs Specialist independently performs regulatory impact assessments for product design, manufacturing, labeling, software, process, supplier, and site changes; prepares technical documentation and regulatory submissions; supports implementation of regulatory pathways and strategies established by the Regulatory Affairs Director; and provides regulatory analysis to support product development, commercialization, change control, and post-market activities. Required: direct, hands-on experience preparing and supporting FDA 510(k)s for medical devices, including substantial equivalence documentation, submission compilation, FDA question responses, and clearance support.
Regulatory Specialist - Rsch Pro 2-Reg Affairs University of MinnesotaRegulatory Specialist - Rsch Pro 2-Reg AffairsMinneapolis, MN$66,000–$85,000 / yearLocated at the heart of one of the nations most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations. Along with study coordinators, assist with scheduling and hosting monitoring visits conducted by internal and external entities, help to resolve findings and report the visits to internal University partners.
Regulatory Affairs Specialist II Benchmark Electronics IncRegulatory Affairs Specialist IIWinona, MN$81,154–$99,453 / yearWhen you join us, you become part of a team passionate about making a meaningful impact across various sectors, including commercial aerospace, defense, advanced computing, next-generation communications, complex industrials, medical, and semiconductor capital equipment. Responsibilities: Working knowledge of ISO 13485, Working knowledge of FDA QSR/QMSR (21CFR part 820), Medical Device Experience, Auditing internal and external, Reviewing and approving of documentation.
Senior Regulatory Affairs Specialist IntegerSenior Regulatory Affairs SpecialistPlymouth, MN$113,025–$165,770 / yearBy living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. Develops US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
Advanced Regulatory Affairs Specialist Bio-Techne CorpAdvanced Regulatory Affairs SpecialistMinneapolis, MN$49,700–$81,650 / yearWhy Join Bio-Techne: We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield. By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics.
Regulatory Affairs Specialist Patterson Companies IncRegulatory Affairs SpecialistSt Paul, MN$77,200–$100,333.33 / yearStrong verbal and written communications with ability to effectively communicate at specialist and line management levels in the organization; strong customer service-oriented skills. Ability to work effectively within a team and as an individual contributor in a fast-paced changing environment -- multi-tasks, prioritizes and meet deadlines in timely manner.
Regulatory Affairs Specialist Oxenham Group LLCRegulatory Affairs SpecialistEagan, MNThe Regulatory Affairs Specialist will maintain global registrations and technical documentation, support audits, manage product compliance throughout the lifecycle, and provide strategic regulatory input to cross-functional teams. Maintain and update European technical files, including risk assessments, usability reports, and clinical evaluations.
International Regulatory Affairs Specialist II - Electrophysiology (on-site) Abbott LaboratoriesInternational Regulatory Affairs Specialist II - Electrophysiology (on-site)Plymouth, MN$61,300–$122,700 / yearThis new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission review of documentation for International geographies (primarily China) regulatory registration, ensuring products and procedures comply with regulations. Support all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
International Regulatory Affairs Specialist II – Electrophysiology (on-site) AbbottInternational Regulatory Affairs Specialist II – Electrophysiology (on-site)MinnesotaThis new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission review of documentation for International geographies (primarily China) regulatory registration, ensuring products and procedures comply with regulations. Support all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Regulatory affairs specialist Karwell TechnologiesRegulatory affairs specialistMinneapolis, MNThe ideal candidate will possess deep knowledge of U.S. and international medical device regulations, strong analytical capabilities, and the ability to collaborate effectively across cross-functional teams to drive compliance and continuous improvement initiatives. This role is responsible for ensuring compliance with global regulatory requirements related to product incident reporting, corrective and preventive actions (CAPA), recalls, field actions, audits, and post-market surveillance activities.