Reg Affairs Specialist II
1 month ago
Recruiter: 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 and high-growth adjacency markets.
In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure, and protecting against sudden cardiac arrest. In addition, we offer solutions with 3D Mapping and Navigation systems, Radiofrequency Ablation catheters, Diagnostic Catheters, EP recording systems, and Intracardiac Access Sheaths. Boston Scientific develops, manufactures, and markets a broad array of products and services that enable less-invasive care for some of the most threatening cardiac conditions. We've been expanding indications and conducting pivotal research for nearly 20 years, resulting in increased access to the lifesaving and life-enhancing benefits of ICD and CRT therapies.
About the role:
Under supervision, the Regulatory Affairs Specialist II is responsible for planning, managing, and implementing regulatory approvals to the FDA, notified body and other country specific product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals.
Your responsibilities will include:
- Researches and advises company on country specific international product registration and compliance related requirements
- Coordinates, compiles, and submits US and international regulatory filings for new and modified products, including IDEs, PMAs, PMA supplements, IDE periodic reports, PMA annual reports, CE Mark dossiers and updates, and other country specific product registrations
- Reviews test protocols and reports for inclusion in regulatory filings
- Assesses labeling, advertising, and promotional materials for regulatory compliance and support of claims
- Reviews product and manufacturing changes for compliance with applicable regulations and impact to regulatory filing
- Represents RA on cross functional product development and manufacturing support teams
- Works with clinical affairs on various aspects of clinical trials and clinical reports
Required qualifications:
- Minimum of a bachelor's degree in life sciences, engineering, or related field
- Minimum of 3 years regulatory experience
Preferred qualifications:
- Working knowledge of regulatory requirements for medical devices
- Effective written and oral communication and technical writing skills
- Basic writing and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
- Experience with Class II or Class III medical devices submissions
- Experience with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
- Experience working directly with FDA, notified bodies and/or international health authorities
- Strong technical, research, problem-solving, and leadership skills
- Ability to communicate complex ideas clearly and simply both orally and in writing
- Demonstrated ability to effectively lead multiple projects and priorities
- Team player with excellent interpersonal skills
Requisition ID:586865
Among other requirements, Boston Scientific maintains specificprohibited substancetest 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. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
-
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...
-
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...
-
Principal Regulatory Affairs Specialist
4 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...
-
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....
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
Sr. Regulatory Specialist
4 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...
-
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...
-
Veterinary Care Specialist II
2 weeks ago
Arden Hills, Minnesota, United States Careerbuilder-US Full timeJob Title: Veterinary Care Specialist II Location: Arden Hills, MN Duration: 12 months+ Full Onsite Schedule: Monday-Friday 7:00AM -4:00PM , some holidays and weekends as needed. Job Overview: Responsible for the upkeep and monitoring of research animal welfare under the guidance of veterinary professionals or study protocols. Core...
-
Logistics Specialist II
2 weeks ago
Arden-Arcade, California, United States Hubbell Power Systems Full timePosition Title: Logistics Specialist IICompany: Hubbell Power SystemsJob Summary:The Logistics Specialist II plays a crucial role in the efficient management of warehouse operations. This position involves the handling of incoming and outgoing shipments, operating specialized vehicles, and ensuring the smooth flow of goods within the facility.Key...
-
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...
-
Reimbursement Pre-Authorization Specialist II
1 month ago
Arden Hills, Minnesota, United States Boston Scientific Full timeAdditional Location(s):US-MN-Arden HillsDiversity - 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 diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the...
-
Quality Assurance Specialist II
3 days ago
Arden Hills, Minnesota, United States Boston Scientific Full timeAbout the Role:Boston Scientific is seeking a Quality Tech II to provide technical assistance to engineering to support manufacturing efforts by implementing corrective and preventative actions. The successful candidate will assist engineers in developing methods and procedures to control or improve manufacturing processes.Your Responsibilities Will...
-
Marketing Communications Specialist
2 weeks ago
Arden Hills, United States Talent Software Services Full timeMarketing Communications Specialist II Job Summary: Talent Software Services is in search of a Marketing Communications Specialist for a contract position in Arden Hill, MN. The opportunity will be one year with a strong chance for a long-term extension. Position Summary: Define and execute communication initiatives that are aligned with overall company...
-
International Regulatory Affairs Strategist
2 weeks 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...