- Health, Dental, Vision and Travel insurance benefits
- Registered Pension Plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Hybrid Work Arrangements (where applicable)
- Parental and Caregiver Leave
- Tuition Reimbursement
-
Central Student Affairs Specialist
1 week ago
Apex Dynamics Flat, United StatesMacromedia as an Employer · Since 2013, Macromedia has been part of the internationally operating education group Galileo Global Education. It provides young people from all over the world with access to higher education degrees. Worldwide, over students are enrolled under the um ...
-
Regulatory Affairs Specialist
1 day ago
Chromatech Inc. & B.V. Canton, United StatesAt Chromatech, we create color solutions in a wide variety of markets around the globe. You can become part of our Chromatech team by joining as a Regulatory Affairs Specialist. The right candidate will leverage their experience, research/analytical skills, and personal drive to ...
-
Regulatory Affairs Specialist
1 week ago
Chromatech Inc. & B.V. Canton, United StatesResponsibilities · Assist in researching regulatory issues associated with various markets. · For customer replies and product marketing, investigate raw material chemical inventories. · Obtain and review supplier documentation, and in coordination with supply chain and the lab ...
-
Regulatory Affairs Specialist
1 week ago
Chromatech Inc. & B.v. Canton, United StatesResponsibilities · Assist in researching regulatory issues associated with various markets. · For customer replies and product marketing, investigate raw material chemical inventories. · Obtain and review supplier documentation, and in coordination with supply chain and the la ...
-
AkzoNobel Troy, United StatesWe've been pioneering a world of possibilities to bring surfaces to life for well over 200 years. As experts in making coatings, there's a good chance you're only ever a few meters away from one of our products. Our world class portfolio of brands - including Dulux, International ...
-
Lease Administrator Manager
4 days ago
ISI Professional Services Sterling, United States**Position Summary**: · ISI is looking for an experienced Lease Administrator Manager with expertise in the Federal Real Property sector to provide lease administration services to the Department of Veterans Affairs. The Lease Administrator will support a VA portfolio of facility ...
-
Donor Intake Nurse
1 week ago
Biolife Plasma Services Detroit, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
-
plasma center paramedic
5 days ago
BioLife Plasma Services Detroit, MI , USA, United StatesBy clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submi ...
-
Plasma Center Nurse- RN
3 days ago
BioLife Plasma Services Detroit, MI, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
-
Clinical Site Coordinator
1 week ago
Wayne State University Detroit, United States Paid WorkClinical Site Coordinator - College of Nursing · Wayne State University is searching for an experiencedClinical Site Coordinator - College of Nursingat its Detroit campus location. · Wayne State is a premier, public, urban research university located in the heart of Detroit, Mich ...
-
Assistance Payments Worker 8
1 week ago
State of Michigan Detroit, United StatesThe MDHHS mission is to provide opportunities, services, and programs that promote a healthy, safe, and stable environment for residents to be self-sufficient. We are committed to ensuring a diverse workforce and a work environment whereby all employees are treated with dignity, ...
-
Clinical Site Coordinator
1 week ago
Wayne State University Detroit, United StatesClinical Site Coordinator - College of Nursing · Wayne State University is searching for an experienced Clinical Site Coordinator - College of Nursing at its Detroit campus location. · Wayne State is a premier, public, urban research university located in the heart of Detroit, Mi ...
-
Bilingual Assistance Payments Worker 8
1 week ago
State of Michigan Detroit, United StatesThe MDHHS mission is to provide opportunities, services, and programs that promote a healthy, safe, and stable environment for residents to be self-sufficient. We are committed to ensuring a diverse workforce and a work environment whereby all employees are treated with dignity, ...
-
Respiratory Sales Specialist, Detroit, MI
1 week ago
Verona Pharma PLC Detroit, United StatesRespiratory Sales Specialist, Detroit, MI (Detroit, MI)", "description": "Respiratory Sales Specialist, Detroit, MI (Detroit, MI) · The Company: · Our mission is to improve the health and quality of life for the millions of people affected by chronic respiratory diseases. We do t ...
-
Adoption Specialist
1 week ago
Ennis Center Detroit, United StatesEOE Statement · We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by ...
-
Nurse Practitioner
1 week ago
Barbara Ann Karmanos Cancer Cn Detroit, United States Full timeUtilizes advanced knowledge and clinicalexpertise to provide specialized health care to individuals, families, groupsand communities across the health-illness continuum. Additionally, functions as a consultant, educator,researcher, resource and role model for patients, families, ...
-
Nurse Practitioner
3 days ago
McLaren Health Care Detroit, MI, United StatesUtilizes advanced knowledge and clinical expertise to provide specialized health care to individuals, families, groups and communities across the health-illness continuum. Additionally, functions as a consultant, educator, researcher, resource and role model for patients, familie ...
-
CSL Seqirus Detroit, United StatesThe Opportunity: · Join our team to develop the CSL Seqirus influenza portfolio for both public and private books of business within a regional geography at Integrated Delivery Networks, Public Health accounts, and other select healthcare sites of care where opportunities for inf ...
-
Manager, Finance
3 weeks ago
Wayne State University Detroit, United States Paid WorkManager, Finance & Administration ASAGE · Wayne State University is searching for an experiencedManager, Finance & Administration ASAGEat its Detroit campus location. · Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan where stu ...
-
Respiratory Sales Specialist, Detroit, MI
1 week ago
Verona Pharma Detroit, United StatesRespiratory Sales Specialist, Detroit, MI (Detroit, MI) · The Company: · Our mission is to improve the health and quality of life for the millions of people affected by chronic respiratory diseases. We do this principally through the development of our first-in-class molecule, e ...
Sr. Regulatory Affairs Specialist, CS - Wayne, United States - Getinge
Description
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 supporting the Cardiac Surgery product area. This position is responsible for activities which lead to and maintain regulatory approval to market medical devices i.e. preparation, submission, tracking of official documents and files. Additionally, it is responsible for assessment of device and labeling changes for regulatory implications.
Key duties and responsibilities:
•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 or compliance issues.
•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.
•Coordinate submission activities for a variety of device regulatory approvals including: US premarket submissions (IDE, 510(k) etc.), international submissions, 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 department/systems development initiatives.
•This is not an inclusive list of job responsibilities
Knowledge/Skills/Experience:
•A Bachelor's degree in a scientific or technical discipline is required or equivalent work experience. Advanced degree preferred.
•A minimum of five years Medical Device Regulatory Affairs experience is required.
•Must have working knowledge of FDA and international regulations/standards.
•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.
Salary range: $105K - $120k
#LI-LG1
About us
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. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. 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 Medtech company.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
Getinge is an equal opportunity employer. Getinge will, at all times, will comply with all applicable human rights and other legislation when considering all qualified applicants for employment. Accommodations are available upon request for candidates taking part in all aspects of the selection process.
