Regulatory Affairs Specialist II

2 months ago

Wayne, United States Getinge Full time

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Getinge is a global company that designs and manufactures medical devices and life science equipment. We impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.

 

We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.

 

We currently have an opening for a Regulatory Affairs Specialist II. This position is responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process.

 

Job Functions:

•Assists with developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.

•Assists with developing and implementing regulatory strategies for new and modified medical devices.

•Acts as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.

•Responsible for preparation and submission of routine regulatory applications, as well as internal regulatory file documentation.

•Reviews device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.

•Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.

•This is not an inclusive list of job responsibilities.

 

Required Knowledge, Skills and Abilities:

•A Bachelor’s degree in a scientific or technical discipline is required or equivalent work experience

•A minimum of two years Regulatory Affairs experience is required. Two to four years Medical Industry experience is preferred.

•Must have working knowledge of FDA and international regulations.

•Must have general understanding of product development process and design control.

•Must have general understanding of regulations applicable to the conduct of world-wide recalls and field actions.

•Must be able to manage several projects.

•Proficiency with Microsoft Office Products such as Word, Excel and Power Point or equivalent software applications is preferred. 

•Must demonstrate effective research and analytical skills.

•Must demonstrate effective written and verbal communication, including technical writing skills.

•Must be able to work independently with minimal supervision.

 

Salary range: $95k-$110k

 

#LI-LG1

 

About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

 

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process. 

  • Regulatory Affairs Assistant

    4 weeks ago

    Wayne, United States Zing Recruiting Full time

    Job DescriptionJob DescriptionFood Science Admin (Regulatory Affairs) OpeningZing Recruiting, in partnership with an established flavor manufacturer in the Wayne, NJ area, is on the search for a sharp Regulatory Affairs Specialist to join their Foods/Nutrition team on a long term contract assignment (minimum 1+ year)! This is an exciting opportunity for...

  • Regulatory Affairs Assistant

    4 weeks ago

    Wayne, United States Zing! Recruiting Full time

    Job DescriptionJob DescriptionFood Science Admin (Regulatory Affairs) OpeningZing Recruiting, in partnership with an established flavor manufacturer in the Wayne, NJ area, is on the search for a sharp Regulatory Affairs Specialist to join their Foods/Nutrition team on a long term contract assignment (minimum 1+ year)! This is an exciting opportunity for...

  • Crisis Intervention Specialist II

    23 hours ago

    Wayne, Michigan, United States Wayne County Regional Educational Service Agency Full time

    Position Overview The Crisis Intervention Specialist II plays a crucial role in supporting students through challenging situations. This position involves: Daily Crisis Support: Provide essential intervention services to students in crisis, ensuring their safety and well-being. Activity Coordination: Organize and lead proactive student engagement activities...

  • Medicare Sales Specialist

    4 hours ago

    Fort Wayne, Indiana, United States Perfiniti Insurance II, LLC Full time

    Position Overview:As a Medicare Sales Specialist at Perfiniti Insurance II, LLC, you will have the opportunity to engage with the Medicare demographic and influence your earnings directly. This role involves fieldwork at various healthcare facilities and community locations, where you will connect with potential clients and assist them in navigating their...

  • Phlebotomy Specialist II

    6 days ago

    Fort Wayne, Indiana, United States Millennium Health Full time

    Position OverviewFull-Time Female Phlebotomy Specialist IILocation: Fort Wayne, Indiana Schedule: Full Time, Varied Hours Seeking: Female candidates are essential for monitored collections of female patients. Join us in making a meaningful difference in your community.Millennium Health LLC is a recognized specialty laboratory with over ten years of expertise...

  • Insurance Claims Specialist II

    6 days ago

    Fort Wayne, Indiana, United States Brotherhood Mutual Full time

    Job Title: Claims Adjuster II - PropertyJob Category: ClaimsFLSA Status: ExemptDepartment: ClaimsJOB SUMMARYThe Claims Adjuster II is accountable for the thorough evaluation and resolution of assigned claims in alignment with the standards of the Claims Department and the objectives of the organization.KEY RESPONSIBILITIESEffectively resolve all assigned...

  • Insurance Claims Specialist II

    5 days ago

    Fort Wayne, Indiana, United States Brotherhood Mutual Full time

    Job Title: Claims Adjuster II - PropertyJob Category: ClaimsRequisition Number: CLAIM001315Location: Fort Wayne, IN (non-remote)JOB SUMMARYThe Claims Adjuster II is responsible for the thorough analysis and resolution of assigned claims in alignment with the standards of the Claims Department and the objectives of the company.POSITION ESSENTIAL FUNCTIONS AND...

  • Insurance Claims Specialist II

    6 days ago

    Fort Wayne, Indiana, United States Brotherhood Mutual Full time

    Job Title: Claims Adjuster II - PropertyJob Category: ClaimsRequisition Number: CLAIM001315Location: Fort Wayne, IN (non-remote)JOB SUMMARYThe Claims Adjuster II is responsible for the thorough analysis and resolution of assigned claims in alignment with the standards of the Claims Department and the objectives of the company.POSITION ESSENTIAL FUNCTIONS AND...

  • Occupational Therapist

    1 week ago

    Wayne, United States Wayne County Regional Educational Service Agency Full time

    We are seeking qualified individuals to fill various ancillary positions on a short-term, temporary basis. OCCUPATIONAL THERAPIST Qualifications: Full approval/licensure from Michigan's Department of Licensing And Regulatory Affairs (LARA) Significan Occupational Therapist, Therapist, Occupational, Healthcare, Education

  • Student Success Specialist

    2 weeks ago

    Fort Wayne, United States University of Hartford Full time

    Reports to Senior Student Success Specialist and CSS Trainer Salary Range: The starting hour rate is $18.75 Weeks Per Year: 52 Work Week: 40 hours (minimum) Position Summary Assumes responsibility for providing quality customer service to all prospective and current students and parents regarding registration, financial aid, loan disbursements, veteran...

  • Fleet Technician

    2 weeks ago

    Fort Wayne, Indiana, United States Sysco Full time

    STEP THREE: Connect with a Sysco talent specialist to discuss the available role (we'll contact you at the number provided)Learn to perform FAI/CVI (Annual) (First Article Inspection - Commercial Vehicle Inspection) inspections on all fleet vehicles including tractors, trailers, converter dollies, light-duty vehicles, and any other company-owned equipment...

  • Accounting Specialist II

    10 hours ago

    Fort Wayne, Indiana, United States Brotherhood Mutual Full time

    Job Title: Accountant II - Affiliates FLSA Status: Exempt Job Family: Affiliates Department: Affiliates - Finance Location: Home Office JOB SUMMARY The Accountant II is accountable for the comprehensive management of the financial records of the company's Affiliates. This role involves overseeing the input of financial transactions, ensuring the precision of...

  • Medical Imaging Specialist

    5 days ago

    Wayne, New Jersey, United States Atlantic Health System Full time

    Position Overview:As a Medical Imaging Specialist, you will be responsible for performing diagnostic imaging procedures utilizing advanced radiologic technology to produce high-quality radiographs for clinical evaluation.Key Responsibilities:1. Execute imaging and treatment protocols in compliance with regulatory standards and professional practices.2....

  • Practical Nurse

    6 days ago

    Wayne, New Jersey, United States Priority Groups Full time

    Position Title: Practical Nurse (LPN) Specialist Location: Preakness Healthcare Center Compensation: $45 to $50 per hour Employment Type: Per Diem Position Summary: Priority Group Services is in search of a skilled and empathetic Practical Nurse (LPN) Specialist to enhance our healthcare team. The LPN Specialist will play a vital role in delivering...

  • Quality Engineer II

    1 week ago

    Wayne, United States Getinge Full time

    With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you...

  • Payroll Specialist

    3 weeks ago

    Wayne, United States Synerfac Technical Staffing Full time $70,000 - $80,000

    Job DescriptionJob DescriptionImmediate Opening for a Payroll Specialist with HYBRID FLEXIBILITY!This is an opportunity to join a well-established global company, and assist with their continued growth.The Payroll Specialist will be handling payroll for multiple locations, while also working with the HR team to support internal employee needs.Primary...

  • Clinical Nurse Specialist

    5 days ago

    Fort Wayne, Indiana, United States Veterans Affairs, Veterans Health Administration Full time

    Overview: The Clinical Nurse Specialist is entrusted with the comprehensive management of the nursing process while delivering and/or overseeing direct patient care. This role emphasizes the importance of care coordination, focusing on patient education, self-management, and satisfaction throughout the healthcare continuum. The nurse administers medications...

  • Community Support Specialist

    5 days ago

    Fort Wayne, Indiana, United States Brightpoint Full time

    Job OverviewAre you seeking a fulfilling career that offers excellent benefits and the opportunity to make a significant difference in the lives of families?POSITION: COMMUNITY SUPPORT SPECIALISTLOCATION: VARIOUS COUNTIESHOURS: FULL-TIME, MONDAY - FRIDAY(ADDITIONAL HOURS AS NEEDED)STARTING SALARY RANGE: $24 PER...

  • Lead Customer Support Specialist

    6 days ago

    Wayne, New Jersey, United States Myrepublicbank Full time

    Lead Customer Support Specialist - MyrepublicbankJob Category: Customer Support Requisition Number: SRUNI002063Position OverviewAs a Lead Customer Support Specialist, you will play a pivotal role in delivering exceptional service to our clients.Key ResponsibilitiesProvide outstanding customer support to enhance client satisfaction.Act as a resource in...

  • Regulatory Compliance Specialist

    5 days ago

    Fort Wayne, Indiana, United States Creative Financial Staffing Full time

    Creative Financial Staffing is collaborating with an innovative financial planning and professional services firm.Key Features of This Role:Engage with a forward-thinking local team focused on future growth and opportunities.This position allows you to contribute your insights and actively participate in shaping strategic initiatives.Comprehensive medical...