1 Regulatory Affairs Specialist Job in Holbrook, MA
Katalyst Healthcares & Life Sciences is Hiring a Regulatory Affairs Specialist Near Holbrook, MA
- 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
Job Summary
Contractor
$103k-132k (estimate)
12/23/2022
06/17/2024
katalysthls.com
South Plainfield, NJ
<25
Related Companies
The job skills required for Regulatory Affairs Specialist include Regulatory Affairs, Product Development, Microsoft Office, Regulatory Compliance, Time Management, Coordination, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Affairs Specialist positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Specialist, it can be promoted into senior positions as a Regulatory Affairs Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Specialist. You can explore the career advancement for a Regulatory Affairs Specialist below and select your interested title to get hiring information.
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