MinneapolisRecruiter Since 2001
the smart solution for Minneapolis jobs

Senior Specialist, Cardiac Rhythm Mgmt, Reg Affairs Job

Company: Boston Scientific
Location: Saint Paul
Posted on: November 11, 2019

Job Description:

Date: Oct 22, 2019 Location: Arden Hills, MN, US, 55112 Company: Boston Scientific Additional Locations: (n/a) Purpose and Passion - Comprehensive Benefits - Life-Work Integration - Community - Career Growth At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose - improving lives through your life's work. 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 cardiac arrest. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets. Position Summary: Under minimal supervision, the Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified body and other country specific regulatory bodies. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews. Position Responsibilities: * Develops domestic and international strategies for regulatory approval of company products * Coordinates, compiles and submits U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country specific product registrations * Develops and maintains positive relationships with regulatory body reviewers through oral and written communications regarding clarification and follow-up of submissions under review * Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings * Represents RA on cross functional product development, manufacturing and clinical support teams and provide regulatory feedback and guidance throughout the product development cycle * Technical and labeling reviews of supporting documents for inclusion in regulatory filings * Represents RA on other cross functional projects which may include process changes and continuous improvement efforts. Qualifications: * BA/BS degree preferably in life sciences or engineering or an equivalent * Minimum 5 years regulatory affairs or related experience. Previous experience with Class III medical devices submissions is desired * Demonstrated proficiency with relevant US/International regulatory requirements for medical devices including Quality Systems standards and clinical investigations * Experience working directly with FDA, notified bodies and/or international health authorities is desired * Strong technical, research and problem-solving skills * Ability to communicate complex ideas clearly and simply both orally and in writing * Demonstrated ability to effectively manage multiple projects and priorities * Team player with excellent interpersonal skills * Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat * Regulatory experience with combination product is a plus About us As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen. Boston Scientific is an Equal Opportunity Employer - Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran Requisition ID: ****** Nearest Major Market: Minneapolis Job Segment: Medical, Cardiac, Engineer, Law, Product Development, Healthcare, Engineering, Legal, Research

Keywords: Boston Scientific, Minneapolis , Senior Specialist, Cardiac Rhythm Mgmt, Reg Affairs Job, Healthcare , Saint Paul, Minnesota

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Healthcare Jobs

PCU Progressive Care Unit Travel Nurse RN
Description: Nationwide Travel Nurse Jobs - Progressive Care Unit RN Are you looking for a new nursing job Would you like to spend the season somewhere you've never been Hospitals nationwide are looking for qualified (more...)
Company: HCEN
Location: Eau Claire
Posted on: 11/14/2019

LPN (Extended) - Mayo Family Clinic Northwest
Description: City br Rochester br br State br Minnesota br br Telecommute br No br br Department br Employee Community Health br br Position description br Location: 41 st Street Professional (more...)
Company: Mayo Clinic
Location: Rochester
Posted on: 11/14/2019

Cath Lab Tech - Days - Eau Claire , WI
Description: FlexCare is a nationwide leader in the staffing of travel nurses and clinicians. With access to thousands
Company: FlexCare Medical Staffing
Location: Eau Claire
Posted on: 11/14/2019

Travel Locum Speech Language Pathologist (SLP) (Eau Claire,WI)
Description: Nationwide Travel Locum Therapist Jobs - Speech Language Pathologist Are you looking for a new therapist job Would you like to spend the season somewhere you've never been Hospitals, Clinics, Outpatient, (more...)
Company: HealthCare Traveler Jobs
Location: Eau Claire
Posted on: 11/14/2019

Liaison RN - Hospice
Description: Description br br Heartland Home Health Care and Hospice -is part of the HCR ManorCare family, a leading provider of home health care, hospice care, skilled nursing, memory care and post-acute care. (more...)
Company: HCR Manorcare Inc.
Location: Saint Cloud
Posted on: 11/14/2019

Description: SunIRef:Nurse:title LICENSED PRACTICAL NURSE DIALYSIS CentraCare Health 151 reviews Saint Cloud, MN 56303 JOB SUMMARY: Provides direct nursing care for individual patients under the direction of the (more...)
Company: CentraCare Health
Location: Saint Cloud
Posted on: 11/14/2019

Physician: 100% Infectious Disease Job Opening in Western Wisconsin - JOB-2377225
Description: An infectious disease position is available at a healthcare system in Wisconsin to take over for a retiring physician. Your schedule will be Monday through Friday with light 1:4 call. You will be supported (more...)
Company: CompHealth
Location: Eau Claire
Posted on: 11/14/2019

Nurse Practitioner - Occupational Health
Description: SunIRef:GP Nurse Practitioner - Occupational Health Marshfield Clinic Health System 273 reviews - Eau Claire, WI Marshfield Clinic Health System 273 reviews Read what people are saying about working here. (more...)
Company: Marshfield Clinic Health System
Location: Eau Claire
Posted on: 11/14/2019

Associate Dentist - Private Practice - $250,000 Salary
Description: General Dentistry opening in Eau Claire, Wisconsin. This and other dentist jobs brought to you by DentistJobCafe.com Position Details: ul li Full Time, Permanent Associate
Company: Infinity Physician Resources
Location: Eau Claire
Posted on: 11/14/2019

Travel Nurse - RN PACU Pre / Post Anesthesia Care
Description: Travel PACU Nurses NeededRecovery Room NursesPost Anesthesia Care Unit Registered NursesMontana Travel RN Nursing Assignments--The Travel Nurse Season is here and it shows--One quick More Info Request (more...)
Company: HealthCare Travelers (Nursing)
Location: Saint Cloud
Posted on: 11/14/2019

Log In or Create An Account

Get the latest Minnesota jobs by following @recnetMN on Twitter!

Minneapolis RSS job feeds