Senior Regulatory Affairs Specialist Pittsburgh, PA Posted: 8/27/2021
Permanent Full Time
Technical Solutions Inc. is currently seeking a Senior Regulatory Affairs Specialist on behalf of our client, a Pittsburgh based manufacturer of medical devices. The Senior Regulatory Affairs Specialist will work closely with the Vice President, Global QA/RA & Technology and the Operations team at the company headquarters regarding regulatory compliance. They will be involved in maintaining a cGMP compliant Quality Management System for a Medical Device manufacturer's implemented systems to ensure the Quality System is established and maintained in accordance with FDA 21 CFR 820, cGMP, MDD 93/42/EEC, MDR 2017/745, and ISO 13485 regulatory requirements.
*Involvement in the maintenance and improvement of the Regulatory environment including the FDA, CE, and related country regulatory requirements globally
*Prepare and maintain regulatory submissions
*Maintain country specific product registrations
*Analyze product changes for impact to current regulatory filings
*Monitor industry regulations and standards for changes and assess impacts to company
*Develop relevant regulatory procedures and work instructions as necessary.
*Ensure conformance to ISO, CE, FDA and other international/local regulations.
*Investigate and document issues relating to the product, process, or Quality System relevant to the regulatory compliance
*Participate in regulatory and internal audits
*Notified Body interaction including required submittals and/or transfers
*Other Quality System related duties as assigned by Management
*Bachelor"s degree (Required)
*Minimum two (2) years Regulatory Affairs experience in Medical Devices (Preferred)
*Experience with FDA, CE MDD/MDR, MDSAP (preferred)
*Ability to create cross-functional partnerships
*Ability to work collaboratively in a team environment
*Effective oral and written communication skills
*Effective problem-solving skills
*Ability to work in a fast-paced environment with the ability to manage multiple, simultaneous responsibilities
*Additional skills: Process Improvement, Analyzing Information, Attention to Detail, Thoroughness, Dealing with Complexity and controversy
Technical Solutions Inc. provides a wide range of staffing services throughout Western Pennsylvania, Ohio and West Virginia. Simplify the job search process by letting us do all the work! With 30 years of expertise, we have the resources, techniques and insights to guide your job search. Our staff will work with you one-on-one to understand your needs and discuss your options. We can even send your resume to multiple job openings that you are a fit for, giving you opportunities to choose from. We reach out to hiring managers for feedback, coordinate and schedule interviews, and advocate on your behalf so that you get the best offer possible. At TSI, we genuinely care about our employees and want to see you succeed. No candidate is ever promised something we do not deliver. The best part is that there are no fees or cost for any of our services. For more information on our company and to view all of our exciting job opportunities, please visit www.tsiwork.com or give us a call at 724-733-2100.