Regulatory Relations Specialist jobs in Brockton, MA
Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)
Recently Added Regulatory Relations Specialist jobs
Regulatory Affairs Specialist
- Katalyst Healthcares & Life Sciences
-
Holbrook, MA
CONTRACTOR
-
Responsibilities:
- Partnering with Product Development and management to prepare and review 510(k) submissions
- Preparing final 510(k) submissions and obtaining required management approvals
- Submitting 510(k) documents and responding to the FDA in a timely manner
- Assisting in the completion of IDE and PMA submissions for IDE clinical trials
- Helping to prepare PMA packages, including non-clinical, manufacturing, and clinical sections
- Working with personnel in various functional areas to obtain timely submissions to FDA
- Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting
- Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes
- Performing routine maintenance of approved PMAs, including coordination and preparation of PMA supplements, Annual Reports
- Training new staff on relevant Regulatory processes as necessary
- Determine Regulatory Pathway for new/changed products under departmental guidelines
- Review and approve Regulatory Pathway Forms and supporting documentation
- Reviewing and approval of Note-to-File documentation for minor changes to 510(k) cleared products or systems
- Understanding the company's products, surgical techniques and the use of implant and instrument systems
- Developing relevant Regulatory SOPs as necessary
- Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
- Representing the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus
- Bachelor's degree in health or science-related field, or equivalent; Engineering degree is a plus
- Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within orthopedic medical devices.
- Experience in medical device development and registration of products
- Demonstrated knowledge of US regulatory submissions; Pre-Sub, and 510(k); working knowledge of IDE and PMA submissions a plus
- Experience assessing regulatory impact of product/process changes
- Experience reviewing labeling, promotional literature, etc.
- Excellent communication and listening skills
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
- Strong time management skills, demonstrated ability to work on multiple projects, priorities simultaneously
- Able to work independently as well as within a team
- 21 Days Ago
Regulatory Affairs Specialist II
- Organogenesis
-
Canton, MA
FULL_TIME
- We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empow...
- 9 Days Ago
Regulatory Affairs Specialist III
- Organogenesis
-
Canton, MA
FULL_TIME
- We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empow...
- 14 Days Ago
Regulatory Affairs Specialist
- Collabera
-
Mansfield, MA
FULL_TIME
- Company DescriptionEstablished in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar I...
- 1 Month Ago
Regulatory Affairs Specialist
- Integrated Resources INC
-
Mansfield, MA
FULL_TIME
- Company DescriptionINTEGRATED RESOURCES STAFFING PVT LTDJob DescriptionJob title: Regulatory Affairs SpecialistLocation: Mansfield, MA Duration: 5 months (possibility of extension) ROLES& RESPONSIBILI...
- 1 Month Ago
Regulatory Affairs Manager / Regulatory Affairs Specialist role
- Collabera
-
Mansfield, MA
FULL_TIME
- Company DescriptionEstablished in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar I...
- 1 Month Ago
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0 Regulatory Relations Specialist jobs found in Brockton, MA area
Senior Regulatory Affairs Specialist
- Convatec Group PLC
-
Lexington, MA
- Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologi...
- 4/25/2024 12:00:00 AM
QA/RA Specialist
- Walker Cole International
-
Boston, MA
- Walker Cole International is searching for a QA/RA Specialist to join a Global Medical Device business in Massachusetts,...
- 4/24/2024 12:00:00 AM
Senior Regulatory Affairs Specialist
- Biofourmis
-
Needham Heights, MA
- Biofourmis brings the right care to every person, no matter where they are. The company's AI-driven solution collects an...
- 4/24/2024 12:00:00 AM
Regulatory Specialist
- PPL Corporation
-
Cumberland, RI
- Company Summary Statement : Rhode Island Energy provides essential energy services to over 770,000 customers across Rhod...
- 4/24/2024 12:00:00 AM
Senior Regulatory Affairs Specialist
- Instrumentation Laboratory Company
-
Bedford, MA
- Responsible for China NMPA and Japan PMDA registration and renewal activities for IL-labeled products. Related duties in...
- 4/23/2024 12:00:00 AM
Principal Regulatory Affairs Specialist
- Instrumentation Laboratory Company
-
Bedford, MA
- Key Accountabilities (Digital Factory Products)Conceive of and Implement the Regulatory Strategy in collaboration with C...
- 4/23/2024 12:00:00 AM
Research Administration Specialist
- Harvard University
-
Cambridge, MA
- Additional Qualifications and Skills Must have familiarity with the federal Uniform Guidance, FAR, NIH policies and proc...
- 4/23/2024 12:00:00 AM
Principal Regulatory Affairs Specialist- USA Remote
- AngioDynamics, Inc.
-
Marlborough, MA
- Performs full-range of regulatory functions required for Global product registrations, new product development, and inte...
- 4/22/2024 12:00:00 AM
About Brockton, Massachusetts
According to the United States Census Bureau, the city has a total area of 21.6 square miles (56 km2), of which 21.5 square miles (56 km2) is land and 0.1 square miles (0.26 km2) (0.56%) is water. Brockton is the 162nd largest city by land area in the Commonwealth, and the twelfth largest of the twenty-seven towns in Plymouth County. Brockton is bordered by Stoughton to the northwest, Avon to the north, Holbrook to the northeast, Abington to the northeast, Whitman and East Bridgewater to the southeast, West Bridgewater to the south, and Easton to the west. Brockton is approximately 25 miles s...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Specialist jobs
$81,059 to $111,280
Brockton, Massachusetts area prices
were up 1.6% from a year ago
were up 1.6% from a year ago
What does a Regulatory Relations Specialist do?
Regulatory Relations Specialist in Albany, GA
The Regulatory Relations Specialist is responsible for the execution of the overall strategy for regulatory engagement and enterprise-wide standards. This includes assisting with the management of regulatory examinations, inquiries and meetings. Additional responsibilities include.
December 09, 2019
Regulatory Relations Specialist in Monroe, LA
We are looking for a Marketing Specialist to plan, coordinate and manage marketing campaigns and activities across marketing channels.
February 06, 2020