Current Job Openings
Director of Regulatory Affairs
PTS Advance is actively hiring a Director of Regulatory Affairs. Our client has an inclusive culture and encourages open discussion and ideas. Be a part of a company that is continuing to improve implantable medical devices and make new discoveries.
We are searching for a talented individual who can share their knowledge of the regulatory environment.
Responsibilities include, but are not limited to:
*Direct the regulatory affairs related activities required for medical device design and manufacturing.
*Work closely with QA department to develop, establish, and implement quality policies and procedures, inspection plans, quality performance trends and continuous improvement initiatives to assure devices meet specifications.
*Participate in design control activities with engineering to identify regulatory related issues during the design phases of device development and device modification.
*Participate in third party audits/assessments, recommend, and manage external audits.
*Coordinate with customers to address/resolve regulatory issues and concerns.
*Direct completion of domestic and international regulatory documents, including but not limited to: US FDA 510(k) submissions; MDD/CE/MDR technical files, design dossiers and/or technical documentation; post-market surveillance and post-market clinical follow up reports; clinical evaluation reports; and customer requested regulatory documentation.
*Direct maintenance and evaluation of domestic and international complaint reporting requirements including adverse event reporting.
*Provide training for regulatory-related topics to all members of the company.
*Participate in professional organization, symposiums and continuing education that will promote and benefit company.
Qualifications:
*Minimum 10 years' experience in medical device Regulatory Affairs.
*Previous management experience
*Knowledge of global medical device regulations and standards including QSR, MDD/MDR and ISO
*Bachelor's degree required; advanced degree preferred.
*Excellent written and verbal communication skills.
Why is this the right fit for you?
*Hybrid schedule with every other Friday off!
*Opportunity to grow and develop your own regulatory team.
*Full medical, dental, and vision.
*401k plan.
*Bonuses
We are actively interviewing! Please reply or email your current resume to Brittany.antonellis@PTSAdvance.com to apply.
