Sr. Regulatory Affairs Specialist - Wayne, NJ
Posted on: May 27, 2023
At Getinge we have the passion to perform
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers - and to save more lives.
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 Sr. Regulatory Affairs Specialist. This position maintains regulatory approval to market medical devices. Additionally, is responsible for assessment of device and labeling changes for regulatory implications.
Job Responsibilities and Essential Duties
--- Develop and maintain positive relationships with U.S. FDA, EU Notified Body and global regulatory agencies through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
--- Develop and deliver presentations to global regulatory agencies. Topics may include submission strategies, compliance issues or new initiatives such as Global Harmonization. Coordinate MAQUET comments on proposed regulations.
--- Develop and implement strategies for regulatory approval of medical devices.
--- Communicate submission and/or advertising and promotion requirements to internal customers such as product development teams and marketing/sales.
--- Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedure/forms.
--- Coordinate submission activities for a variety of device regulatory approvals including: US premarket submissions (IDE, 510(k), PMA, etc.), international design dossiers/technical files, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings.
--- Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes.
--- Serve as internal consultant on regulatory issues such as recalls, advertising and promotional activities, field actions or review of proposed device changes.
--- Participate in training and mentoring of staff
--- Coordinate IFU development activities
--- Participate in department/systems development initiatives
--- 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. An engineering or Advanced degree preferred.
--- A minimum of five years Medical Device Regulatory Affairs experience is required. Minimum 2yrs mechanical engineering experience preferred along with software experience.
--- Must have working knowledge of FDA and international regulations.
--- Must have general understanding of product development process and design control.
--- Must be able to manage several projects simultaneously.
--- 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.
Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. Our passionate people hold our brand promise 'Passion for Life' close to heart.
If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world's most respected and trusted MedTec company.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
At Getinge we have the passion to perform
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