Regulatory Affairs Specialist

Job Description

Insight Global is looking for a Regulatory Affairs Specialist that will be responsible for the regulatory functions including support of labeling requirements, serving as regulatory representative on selected project teams. You will also support compilation and submission of regulatory submissions for biologics products primarily but may assist with other product portfolio as needed.

Day to Day Responsibilities:

• Provide regulatory guidance to quality systems, manufacturing, marketing and product development groups
• Represent regulatory on various projects supporting compliance for biologics (Human Tissue Based and Medical Devices) products
• Provide regulatory guidance to design team for device labeling, promotional materials, and sales training material
• Prepare and submit regulatory filings for new products or changes to existing products, including management of interactions with regulatory authorities and ensuring that all activities are accurately and timely documented
• Support compilation and maintenance of design dossiers and technical flies
• Work with other cross functional members in support of international registrations, renewals and tenders
• Maintain current knowledge of new regulations, policies, guidance documents, etc. issued by relevant regulatory authorities, which may impact the company
• Perform other duties as assigned

Skills and Requirements

• Bachelors Degree
• 3-5 years of experience in with the biologics or medical device industry in the regulatory affairs field.
• Experience preparing and submitting documents sent over to government agencies
• Experience preparing and executing regulatory presentations
• Experience with orthopedic devices
• Experience with blood, human, cell, tissue based products

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].