Top 2018 Rac Jobs | SimplyHired

Regulatory Affairs Specialist
elliquence, LLC —Baldwin, NY
- $75,000 - $85,000 a year
- Full-time
- Background check
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
Oracle Database Administrator
HCL Technologies Limited - Business Services —Arden Hills, MN
- $77,000 - $138,000 a year
- Email
- Background check
- System design
- Microsoft Office
- AD&D insurance
- Paid holidays
Quick Apply
RAC Component Design Engineer (Ventilation)
System One —Bellevue, WA
- $50 - $80 an hour
- Contract
- Bachelor of Science
- Senior level
- 4 years
- Health insurance
- Dental insurance
Quick Apply
RAC System Engineer (Process & I&C)
System One —Bellevue, WA
- $54 - $90 an hour
- Contract
- 6 years
- Bachelor of Science
- Senior level
- Health insurance
- Dental insurance
Quick Apply
MDS Coordinator
Ascent Healthcare Management —North Carolina
- $32 - $41 an hour
- Full-time
- Skilled nursing facility
- RN License
- Ability to walk for extended periods
Quick Apply
GSD Support Associate
Konica Minolta Business Solutions, U.S.A., Inc. —Odessa, TX
- Full-time
- Remote
- Travel
- Communication skills
- Commercial
Managed Care Appeals Analyst
Elevate Patient Financial Solutions —Remote
- $23.00 - $28.28 an hour
- Full-time
- Remote
- Microsoft Word
- Surgery
- Writing skills
- Paid holidays
- Health insurance
Quick Apply
Appeals Supervisor
TeamHealth —Remote
- Overtime
- Remote
- Mid-level
- Travel
- Recruiting
11d
Director of Sales
Konica Minolta Business Solutions, U.S.A., Inc. —Houston, TX
- Full-time
- Remote
- Leadership
- Commercial
Exacc/ Database Patch Engineer - W2 Only
Digital iTechnology —Remote
- $47 - $50 an hour
- Contract
- Remote
- Senior level
Quick Apply
10d
Government Accounts Manager
Konica Minolta Business Solutions, U.S.A., Inc. —Phoenix, AZ
- Full-time
- Remote
- Travel
- Organizational skills
- Commercial
10d
BSC Supervisor
Konica Minolta Business Solutions, U.S.A., Inc. —Lenexa, KS
- Full-time
- Ability to lift 75 pounds
- Commercial
RAC TEACHER
Rowan-Salisbury Schools —Salisbury, NC
- $4,100 a month
- Full-time
- Classroom
- Management
- Mid-level
Oracle Engineered Systems DBA
CENTROID —Remote
- Full-time
- Remote
- 5 years
- SQL
- Senior level
Quick Apply
Director, Quality Assurance (Quality Systems)
Syncromune —Remote
- $210,000 - $230,000 a year
- Full-time
- 5 years
- Travel
- Senior level
Quick Apply
Finance Worker
CNH Industrial —Waterford, WI
Account Executive
Kinetix —Remote
- $60,000 - $80,000 a year
- Full-time
- Remote
- Customer service
- Mid-level
- 3 years
CIT, RAC, CAC, LAC
Exceptional Behavioral Health Services, LLC —Chalmette, LA
- $27 - $40 an hour
- Part-time
- Hybrid work
- Addiction Medicine
- Mid-level
- US work authorization
Quick Apply
12d
RAC Technician
Rittal LLC —Houston, TX
- $21.87 an hour
- Full-time
- Ability to walk for extended periods
- High school diploma or GED
- Ability to lift 50 pounds
- Health insurance
- Tuition reimbursement
Quick Apply
Senior Manager, Compliance Services
MediSpend —Remote
- $120,000 - $150,000 a year
- Full-time
- Remote
- 5 years
- Analysis skills
- Bachelor's degree
- Paid parental leave
- Health savings account
Quick Apply
13d

I want to receive the latest job alert for rac

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Regulatory Affairs Specialist

elliquence, LLC -
Baldwin, NY

Quick Apply

Job Details

Full-time
$75,000 - $85,000 a year

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance

Qualifications

Medical device validation
Regulatory Affairs Certification (RAC)
Process improvement standards implementation
Regulatory compliance
Biomedical Engineering
Bachelor's degree
Health Science
Regulatory affairs
Biomedical regulatory compliance
Manufacturing

Full Job Description

About the job
This role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.

Key Responsibilities:
Primary Responsibilities

Assist in the preparation, formatting, and collection of regulatory submissions
Ensure the maintenance of regulatory files, declarations of conformity, and device listings/registrations are accurate and complete.
Oversee inquiries into regulatory agency requests for additional information for document submission.
Support U.S. and EU market approval processes and ensure compliance with regulatory standards
Support post-market submissions (progress reports, annual reports, etc.)
Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers.
Communicate with distributors in response to requests for information, regulatory inquiries or in support of regulatory filings.

Compliance & Quality System Support

Partner with Quality Assurance to ensure continued compliance with applicable regulatory standards, including FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745.
Support in audits (internal and external) in document preparation as needed.
Support document control and recordkeeping to ensure regulatory documentation integrity and traceability.
Assist in preparing regulatory applications that are compliant with applicable regulatory requirements to achieve business objectives.

Cross-Functional Collaboration

Partner with Engineering and Clinical teams to gather information needed for submissions and documentation.
Assist in preparing summaries, tracking deliverables, and ensuring timely submission of regulatory documents.
Support training and awareness initiatives related to regulatory compliance.
Interpret new or existing regulations and ensure business practices align with compliance requirements.
Create documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance.
Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to other teams/departments and executive leadership.
Establish and maintain regulatory information systems.
Contribute in continuous improvement initiatives and process optimization within Regulatory Affairs.

Qualifications:

Bachelor's degree in biomedical, RA/QA or related scientific area for medical device industry (RAC certification preferred).
Master’s degree in related field can count towards 1 year of relevant experience.
3-5 years of experience in a regulated FDA environment (medical devices or combination products).
Hands-on experience with 510(k) submissions (IDE and PMA knowledge a plus). Strong knowledge in regulatory strategy and approval approaches.
Strong understanding of FDA and EU medical device regulations (international experience desirable).
Working knowledge of FDA, EU MDR, or ISO regulatory environments preferred.
Audit experience as a contributor is preferred.
Ability to efficiently navigate through the regulatory process either individually or in a team setting ensuring a project’s success.
Strong organizational, communication (verbal and written), and planning skills.
Ability to interact cross functionally across multiple departments with various levels of the organization.
Detail oriented, practical and proactive problem solver.
Proficiency with PC systems and office applications.
Solid understanding of scientific principles applied to regulatory affairs.
Understanding of regulatory and business needs with ability to engage cross functional team members.

Salary range is $75,000- $85,000/annual USD

An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits.
We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state and local laws.
We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email [email protected].

Job Type: Full-time

Pay: $75,000.00 - $85,000.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Ability to Commute:

Baldwin, NY 11510 (Required)

Ability to Relocate:

Baldwin, NY 11510: Relocate before starting work (Required)

Work Location: In person

Quick Apply

Refine Your Search

rac jobs

Regulatory Affairs Specialist

Oracle Database Administrator

RAC Component Design Engineer (Ventilation)

RAC System Engineer (Process & I&C)

MDS Coordinator

GSD Support Associate

Managed Care Appeals Analyst

Appeals Supervisor

Director of Sales

Exacc/ Database Patch Engineer - W2 Only

Government Accounts Manager

BSC Supervisor

RAC TEACHER

Oracle Engineered Systems DBA

Director, Quality Assurance (Quality Systems)

Finance Worker

Account Executive

CIT, RAC, CAC, LAC

RAC Technician

Senior Manager, Compliance Services

I want to receive the latest job alert for rac

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected