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Principal Regulatory Affairs Specialist
4 weeks ago
Recruiter: Spencer Gregory Hale Principal Regulatory Affairs Specialist About the role: The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory product approval processes. Acts as a primary Regulatory Affairs representative in Material Controls, Supplier Quality and Medical Electrical Equipment spaces. Additionally, the Associate is responsible for representing regulatory interests within quality system projects and process changes, process ownership and audit support. Your responsibilities will include: Perform as the Regulatory Affairs Lead team member on initiatives to transform how we address the unique needs of capital equipment life cycle within the quality system (from part creation, labeling and testing to distribution and servicing). Collaborate with cross functional partners (specifically Supplier Quality, Material Controls and Design Controls) as the Voice of Regulatory to deliver innovative solutions for achieving and maintaining compliance in the areas of Medical Electrical Equipment, Material Controls, Supplier Quality, and others. Proactively influence global site and divisional partners and leadership in interpretation/understanding of new concepts and requirements and adoption of Best Practices. Partner with cross divisional team members and business unit and country regulatory affairs to identify process gaps and opportunities for process efficiencies. Identify, establish business cases for, initiate and lead projects to address needs within the medical equipment space. Actively participate in various Quality System Community of Practice teams representing Regulatory Affairs interests, assessing impact, and bringing awareness to Regulatory Teams. Actively participate in advocacy streams to get a pulse on regulation trends and expectation as well as benchmark against other industry leaders. Author, revise and edit standard operating procedures and work instructions. Participate as the Regulatory Affairs SME in assessments for global requirement changes and collaborate with cross-functional partners to influence changes to the quality system as needed. Coordinate regulatory strategy and execute on deliverables to allow for implementation of manufacturing process changes impacting multiple divisions. Participate in training and mentoring of staff. Participate in department systems development initiatives. Required qualifications: Minimum of a Bachelor’s degree Minimum of 5 years’ experience in Regulatory Affairs or a related discipline (e.g. Quality Systems, R&D, Quality, Post Market) within the medical device, IVD, pharmaceutical or healthcare industries Working knowledge of FDA, EU and/or international medical device regulations Experience with audits from regulatory bodies (e.g. MDSAP and ISO 13485) Ability to read and interpret global regulations and standards General understanding of product development process, design controls and quality system regulations Proficiency with Microsoft Office applications (Teams, Word, Excel, PowerPoint) Preferred qualifications: Degree or work experience in a scientific or technical discipline Experience of managing complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization. Excellent written and oral communication, technical writing and editing skills Excellent research and analytical skills Ability to manage multiple projects simultaneously High sense of urgency and commitment to execution. Proven leadership, collaboration and influencing skills Willingness to travel to divisions, regions, and corporate headquarters (estimate 10% travel in non-pandemic conditions) Requisition ID: 588395 Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. #J-18808-Ljbffr
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Principal Regulatory Affairs Specialist
1 month ago
Arden Hills, Minnesota, United States Boston Scientific Full timeRecruiter: Spencer Gregory HalePrincipal Regulatory Affairs SpecialistAbout the role:The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory product approval processes. Acts as a primary Regulatory Affairs representative in Material Controls, Supplier Quality and Medical Electrical Equipment spaces....
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Principal Regulatory Affairs Specialist
1 month ago
Arden Hills, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Principal Regulatory Affairs Specialist About the role:The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory product approval processes. Acts as a primary Regulatory Affairs representative in Material Controls, Supplier Quality and Medical Electrical...
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Principal Regulatory Affairs Specialist
1 month ago
Arden Hills, Minnesota, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Principal Regulatory Affairs Specialist About the role:The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory product approval processes. Acts as a primary Regulatory Affairs representative in Material Controls, Supplier Quality and Medical Electrical Equipment...
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Principal Regulatory Affairs Specialist
3 weeks ago
Arden Hills, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Principal Regulatory Affairs Specialist About the role:The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory product approval processes. Acts as a primary Regulatory Affairs representative in Material Controls, Supplier Quality and Medical Electrical Equipment...
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Principal Regulatory Affairs Specialist
1 month ago
Arden Hills, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Principal Regulatory Affairs Specialist About the role:The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory product approval processes. Acts as a primary Regulatory Affairs representative in Material Controls, Supplier Quality and Medical Electrical Equipment...
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Principal Regulatory Affairs Specialist
2 weeks ago
Arden Hills, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Principal Regulatory Affairs Specialist About the role:The Regulatory Associate is responsible for activities which lead, improve and drive efficiencies across regulatory product approval processes. Acts as a primary Regulatory Affairs representative in Material Controls, Supplier Quality and Medical Electrical...
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Senior Regulatory Affairs Consultant
1 week ago
Arden Hills, Minnesota, United States Boston Scientific Full timeRecruiter: Spencer Gregory HalePosition: Principal Regulatory Affairs SpecialistOverview:The Principal Regulatory Affairs Specialist plays a pivotal role in enhancing and streamlining regulatory product approval workflows. This position serves as a key representative for Regulatory Affairs within the realms of Material Controls, Supplier Quality, and Medical...
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Senior Regulatory Affairs Consultant
1 week ago
Arden Hills, Minnesota, United States Boston Scientific Full timeRecruiter: Spencer Gregory HalePosition Overview:The Principal Regulatory Affairs Specialist plays a crucial role in enhancing and streamlining regulatory product approval workflows. This position serves as a key Regulatory Affairs representative within the domains of Material Controls, Supplier Quality, and Medical Electrical Equipment.Moreover, the...
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Senior Regulatory Affairs Consultant
1 week ago
Arden Hills, Minnesota, United States Boston Scientific Full timeRecruiter: Spencer Gregory HalePosition Overview:The Principal Regulatory Affairs Specialist plays a crucial role in enhancing and streamlining regulatory product approval processes. This position serves as a key representative in the domains of Material Controls, Supplier Quality, and Medical Electrical Equipment.Moreover, the Specialist is tasked with...
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Regulatory Affairs Specialist
2 months ago
Laguna Hills, United States Actalent Full timeDescription: This position is a regulatory affairs specialist for a medical device company. Individual must be knowledgeable in medical device industry and have Class II or Class III device experience. Candidate will: Prepare documentation for regulatory submissions and registrations (FDA, EU, and Canada regulatory entities) IDE, PMA, 510(k), Design...
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Sr. Regulatory Specialist
4 weeks ago
Arden Hills, Minnesota, United States Boston Scientific Full timeRecruiter: Spencer Gregory HaleSr. Regulatory Specialist - Electrophysiology Pulsed Field AblationAt Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden...
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Reg Affairs Specialist II
1 month ago
Arden Hills, Minnesota, United States Boston Scientific Full timeRecruiter: Spencer Gregory HaleReg Affairs Specialist II - CRMYou'll discover a place where you can have meaningful purpose, improving lives through your life's work. Our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and...
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Reg Affairs Specialist II
1 month ago
Arden Hills, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Reg Affairs Specialist II - CRM You'll discover a place where you can have meaningful purpose, improving lives through your life's work. Our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies...
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Reg Affairs Specialist II
2 weeks ago
Arden Hills, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Reg Affairs Specialist II – CRM You’ll discover a place where you can have meaningful purpose, improving lives through your life's work. Our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new...
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Regulatory Affairs
3 months ago
Agoura Hills, United States Brazilian Professionals Full timeJob DescriptionJob DescriptionThe Regulatory Affairs & Documentation Specialist is responsible for formatting, assembling, and timely preparation of documents for domestic and international regulatory submissions and ensuring compliance with applicable regulations.Assists with technical/regulatory aspects of product development.Under general supervision of...
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International Regulatory Affairs Strategist
1 week ago
Short Hills, New Jersey, United States CapLeo Global Full timeJob Title: International Regulatory Affairs Strategist Location: Remote Duration: 6 MonthsJOB DESCRIPTION Act as a key liaison among Country Regulatory Managers and Global Regulatory Teams, Development Teams, Brand Teams, and Operating Committees.Collaborate with local Regulatory Affairs Specialists to formulate, implement, and execute regulatory strategies...
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Sr. Regulatory Specialist
3 weeks ago
Arden Hills, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Sr. Regulatory Specialist - Electrophysiology Pulsed Field Ablation At Boston Scientific, you'll discover a place where you can have meaningful purpose, improving lives through your life's work. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure and protecting against sudden...
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Scientific Affairs Principal,Rhythm Management-
1 month ago
Arden Hills, Minnesota, United States Boston Scientific Full timeAdditional Location(s):US-MN-Northern/Duluth; US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-PlymouthDiversity - Innovation - Caring - Global Collaboration - Winning Spirit- High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of...
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Senior Manager, CMC Regulatory Affairs
1 week ago
Short Hills, New Jersey, United States V R Della Infotech Inc Full timeJob OverviewPosition: Senior Manager, Regulatory Affairs - CMCWork Arrangement: Hybrid (50% onsite)Compensation: Competitive hourly rateRole Summary:The Senior Manager in Regulatory Affairs will play a pivotal role in shaping the CMC regulatory strategy for post-approval submissions of small molecule products. This position requires a deep understanding of...
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Senior Manager, CMC Regulatory Affairs
1 week ago
Short Hills, New Jersey, United States V R Della Infotech Inc Full timeJob OverviewPosition: Senior Manager in Regulatory & Medical Affairs - CMCWork Arrangement: Hybrid (50% onsite)Compensation: Competitive hourly rateKey ResponsibilitiesThe successful candidate will be responsible for a variety of tasks, including but not limited to:Contributing to the formulation of the CMC regulatory strategy for post-approval submissions...