- A Commitment to the Highest Standards of Quality
- Relentless Innovation
- Operational Excellence
- Under minimal supervision, acts as company representative, 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.
- Assist with developing and implementing regulatory strategies for new and modified medical devices.
- Research and prepare recommendations on pathway for a new device, proposed device change or modification to support International Registrations.
- Apply scientific/technical knowledge to guide and strengthen development of regulatory submissions.
- Compile necessary information and prepare Regulatory license applications that meet specific country requirements to support international markets, as well as internal regulatory file documentation
- Prepare and maintain Technical Documentation Files (EU Tech Files and Design Dossiers; and IC Dossiers)
- Review device labeling and advertising materials for compliance with regulatory product approvals (submissions/licenses) and applicable country regulations; analyze and recommend appropriate changes.
- Review and recommend action on product and manufacturing changes in compliance with applicable regulations.
- May act as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
- Prepare Export Certificates (CFGs, CFS, etc.)- apply knowledge of specific country requirements to obtain approvals from USA regulatory agencies and International embassies
- Prepare product and establishment registration/listing with International Regulators primarily for the EU and APAC.
- Collaborate with internal (Quality/Ops/R&D) and external (Partners/Distributors) groups to obtain documentation necessary to develop required Field Action reports to Regulators (e.g., FDA, CA, EU) including Initial, Interim and Close-out Report
- Liaison with global Regulatory partners.
- Contribute as a team member on projects sustaining the regulatory and quality compliance of products and the continued enhancement of the organization
- Support and maintain Quality initiatives in accordance with the Quality Policy.
- Continuously assess ways to improve Quality.
- This position has potential for travel to domestic and international facilities and meetings.
- May perform other duties as assigned
- Manages in order to ensure compliance with all relevant regulatory/legal requirements.
- Build Quality into all aspects of their work by maintaining compliance to all quality requirements
- Bachelors Level of Degree in a scientific or technical discipline field of study
- Equivalent work related experience acceptable in lieu of degree
- 1-2+years of experience in Regulatory Affairs supporting EU MDR/International registrations.
- Medical industry experience required.
- Experience in the following computer software applications: Microsoft Office
- General understanding of product development process and design control.
- Effective written and oral communication, technical writing and editing skills.
- Effective research and analytical skills.
- Ability to work independently with minimal supervision.
- Working knowledge of FDA and international regulations.
- Ability to manage several projects simultaneously
- Exceptional interpersonal skills.
- Strong organizational skills.
- Strong communication skills (written and verbal).
- Ability to effectively communicate both internally and externally.
- Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals. Ability to write routine reports and correspondence.
- This position requires some travel up to 5% of the time
-
Teen Coordinator, Temporary 3-6 Months
4 days ago
Boys & Girls Club of Worcester Worcester, United States**The Boys & Girls Club of Worcester is a nonprofit, charitable, educational organization recognized as a leading advocate for youth development, working to help youth of all backgrounds.** · Come make a difference with us Our history and our mission is this: Boys & Girls Clubs o ...
-
Shipper/receiver(Temp 6 Month Contract)
2 days ago
Groe Advisors LLC Southborough, United States**Shipper/Receiver(6 Month Temp Contract)** · **Location: Southborough, MA** · **ROLE SUMMARY - **We are currently looking for a Shipper/Receiver to join our Supply Chain Operations based in Southborough MA. The Shipper/Receiver role will work closely with the rest of the warehou ...
-
Program Specialist
1 day ago
US United States Army Futures Command Natick, United States**Duties**: · - Support Operations Support Team Lead with day-to-day operations of the team. · - Train and become adept at using existing and new software solutions that support business processes in a shared environment, e.g. tasker management. · - Provide customer service to an ...
-
Junior Bio Process Associate
4 days ago
TechData Service Company, LLC Devens, United StatesThis role is in Devens, MA---100% Onsite, Some OT required as needed · Duration: 6 months and has a chance to extend · **Responsibilities**: · Operates control systems and processes in Biotechnology Pilot Plants as assigned. · Prepares process buffers and reagents. Cleans equipme ...
-
Light Industrial Warehouse Associate
3 days ago
Commoneo LLC Devens, United States**Job Description: Warehouse Associate, 6 month assignment with Possible Temp to Perm at conclusion of assignment. Training for 1st week, 2 days of computer training and 3 days of hands on depending on experience.** · **Work Hours: Monday through Friday 8:00 AM to 5:00 PM and OT ...
-
Customer Service Coordinator
21 hours ago
KMC Solutions Devens, United States_**Are you seeking a career opportunity with potential for growth, advancement, and the possibility of transitioning from temporary to permanent employment? Consider joining our AEROSPACE client in Devens, MA Upon conversion, you'll have access to excellent benefits**_ · - **We a ...
-
Youth Mentor
1 week ago
Regional Environmental Council Worcester, United States**Job Title**:Youth Mentor · **Compensation**:$16.50/hour · **Supervision**:This position reports to the YouthGROW Coordinators · **Status**: Non-exempt · **Category**:Part-time / Temporary · **Start Date/End Date**: Start Date: June 10th, End August 21st · **Hours**:20-30 hours ...
-
Disaster Response
1 week ago
ANSER Suffolk, United States**Company Overview**: · Analytic Services Inc (ANSER) enhances national and homeland security by strengthening public institutions. We provide thought leadership for complex issues through independent analysis and we deliver practical, useful solutions. ANSER values collaboration ...
-
Quick Reaction Test Planner
1 week ago
ANSER Suffolk, United States**Company Overview**: · Analytic Services Inc (ANSER) enhances national and homeland security by strengthening public institutions. We provide thought leadership for complex issues through independent analysis and we deliver practical, useful solutions. ANSER values collaboration ...
-
Legal Administrative Assistant
3 days ago
Bowditch & Dewey, LLP Boston, United States**Company Overview**: · We are seeking a highly organized and detail-oriented individual to join our team as a **temporary **legal administrative assistant. In this role, you will provide essential administrative support to our Boston office team. This is full time position, on-s ...
-
Summer Program Coordinator
1 day ago
Spanish American Center, Inc. Leominster, United States**Summer Program Coordinator** · **Full time position** · **Educational and recreational activities,, Monday-Friday 8:30 a.m.5:00 p.m. with youth ages 8 to 13** · **Summer Program Verano Alegre, Coordinator, ** is responsible for assisting with development of the activity schedul ...
-
Brigham & Women's Hospital(BWH) Boston, United States**NURSE EDUCATOR/ TEMPORARY/ CRITICAL CARE/ EVES** · **INSTRUCTOR/ TEMPORARY CLINICAL NURSE EDUCATOR/ CRITICAL CARE/ 40 HOURS/ EVENING SHIFT/ BOSTON** · **GENERAL OVERVIEW**: · The Clinical Nurse Educator/Instructor reports to a designated Professional Development Manager and dem ...
-
Temporary Registered Nurse
1 week ago
HRI Hospital Brookline, United States**Registered Nurse (RN) Opportunity - $60 per hour, 6 Month Contract** · This is a full time 6 month assignment opportunity with the opportunity to work Day (7am - 3:30pm), Evening (3pm-11pm) or the Overnight (11pm-7am) shift. New graduates are welcome to apply · **HRI Hospital** ...
-
Phlebotomist I
1 week ago
Talentrupt Brookline, United States**Job Details** · **Job Title: Phlebotomist I** · **Location: 1180 Beacon St, Brookline MA 02446** · **Contract: 7 Months Contract** · **Shift: 1st Shift (8 am to 4:30 pm)** · **Pay Rate: $ 21/Hr.** · **Job Summary** · - Represents the face of the company to patients who come in, ...
-
Bft Lpn Needed at Waltham Walk In
1 day ago
Massachusetts General Hospital(MGH) Boston, United States**BFT LPN NEEDED AT WALTHAM WALK IN** · Newton-Wellesley Hospital is a comprehensive medical center located in Newton. We provide the services and expertise of a major medical facility with the convenience and personal attention of a community hospital. Our team is committed to d ...
-
Outreach Housing Stabilization Supervisor
4 days ago
Pine Street Inn Boston, United States**SCHEDULE**:Monday - Friday, 8:00 a.m. - 4:30 p.m., evenings and weekends as needed · **Pays $29.55 per hour DOE** · **This position carries a retention bonus of $5000.00, payable in equal instalments of $1000 at 3 months, $1000 at 6 months, and $3000 at 1 year.** · This bonus i ...
-
Vp Manufacturing
1 week ago
The Verity Collective Chelmsford, United States**The need**: · We are seeking an experienced manufacturing and operational consultant to help and assist with a plan for future volume scale of our products. This individual will help scale manufacturing volume more efficiently at a lower cost while being focused on improving yi ...
-
Per Diem Clinical Assistant- Dermatology
1 week ago
Boston Children's Hospital Boston, United States75195BR · - Ambulatory Services · **Job Posting Description** · - The Clinical Assistant will be responsible for: · - Supporting Allergy, Dermatology, Hematology, Immunology, and Rheumatology clinical specialties at 300 Longwood and 2 Brookline Place. · - Assisting clinician duri ...
-
Freelance Photographer
4 days ago
Coffee Pond Photography and Yearbooks Braintree, United States_School Portrait Photographer _ · Are you a talented portrait photographer looking to supplement your business with some consistent work in the fall? Coffee Pond Photography could be the perfect fit · We are currently seeking dependable, skilled photographers to join our school p ...
-
Freelance Photographer
4 days ago
Coffee Pond Photography and Yearbooks Boston, United States_School Portrait Photographer _ · Are you a talented portrait photographer looking to supplement your business with some consistent work in the fall? Coffee Pond Photography could be the perfect fit · We are currently seeking dependable, skilled photographers to join our school p ...
Regulatory Affairs Specialist Temporary 12 Months - Marlborough, United States - AngioDynamics
Description
JOIN A TEAM COMMITTED TO IMPROVING PATIENT CARE
It takes a team of talented people to become one of the world's leading providers of innovative medical devices.
AngioDynamics is dedicated to improving patient outcomes by focusing on the development of disruptive and differentiated technologies that address unmet patient needs and supporting professional healthcare providers around the world in the delivery of high-quality patient care.
We accomplish this through:
We are pleased to offer a comprehensive benefit plan that supports the overall health and wellness needs of our employees and their families.
Job Summary
Responsible for determining the path to market for new and modifications to existing products in compliance with Regulations of intended market territory and for guiding teams on the required deliverables to support the Regulatory status of products distributed by AngioDynamics Inc.
Essential Duties and Responsibilities
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job:
§ Work safely and follow all OSHA regulations and company safety policies and procedures.
§ For all on-the-job injuries or accidents, must notify manager/supervisor immediately.
§ Exposure to standard office environment
§ Ability to frequently lift and/or move up to 15 lbs
§ Ability to occasionally lift and/or move up to 50lbs
§ Ability to regularly sit or stand for extended periods of time
The Company will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
AngioDynamics does not accept resumes or candidate submissions from third-party recruiters and/or vendors who are not expressly under current written contract.
Your ultimate salary may vary depending on your job-related skills, knowledge, and experience.
&v=024){kind=logo}
&v=024){kind=logo}
