US_East | Software Developer - Database_L3

"Possible 3 Month CTH | No Fees | Do Not Re-Post| ConfidentialTMR ID: 2KTFJSRole: Regulatory affairs specialistWork location: Hybrid, Maple Grove, Minnesota (3 days onsite weekly)Background and Meet and Greet: MANDATORYJob Description:"Position SummaryHighly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division. This role is responsible for ensuring compliance with global regulatory requirements related to product incident reporting, corrective and preventive actions (CAPA), recalls, field actions, audits, and post-market surveillance activities.The ideal candidate will possess deep knowledge of U.S. and international medical device regulations, strong analytical capabilities, and the ability to collaborate effectively across cross-functional teams to drive compliance and continuous improvement initiatives.Key Responsibilities Lead regulatory activities supporting product corrections, recalls, and field actions. Partner with internal global regulatory teams and external regulatory authorities regarding recall-related communications and submissions. Manage Product Incident Reports (PIRs), including investigation, risk assessment, documentation, and regulatory reporting. Drive development, implementation, and monitoring of CAPAs to address nonconformances and improve regulatory processes. Support internal and external audits, inspections, and compliance assessments. Ensure compliance with FDA regulations, EU MDR requirements, and other international regulatory frameworks. Monitor evolving global regulatory requirements and communicate regulatory updates to stakeholders. Provide regulatory guidance for post-market surveillance and quality-related activities. Develop and deliver regulatory compliance training to internal teams. Collaborate with Quality, Clinical, Engineering, Manufacturing, and Commercial teams to ensure regulatory compliance throughout the product lifecycle. Required Qualifications Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related scientific/technical discipline, along with 12+ years of relevant industry experience. Minimum 5 years of experience in Regulatory Affairs and/or Quality within the medical device, healthcare, or life sciences industry. Minimum 2 years of direct Regulatory Affairs experience. Strong knowledge of U.S. FDA regulations and medical device regulatory requirements. Experience managing: Product Incident Reports (PIRs) Corrective and Preventive Actions (CAPAs) Product recalls and field corrective actions Audit and inspection support activities Experience using regulatory systems, databases, and documentation tools. Strong written and verbal communication skills."Key Responsibilities:" Lead regulatory activities supporting product corrections, recalls, and field actions. Partner with internal global regulatory teams and external regulatory authorities regarding recall-related communications and submissions. Manage Product Incident Reports (PIRs), including investigation, risk assessment, documentation, and regulatory reporting. Drive development, implementation, and monitoring of CAPAs to address nonconformances and improve regulatory processes. Support internal and external audits, inspections, and compliance assessments. Ensure compliance with FDA regulations, EU MDR requirements, and other international regulatory frameworks. Monitor evolving global regulatory requirements and communicate regulatory updates to stakeholders. Provide regulatory guidance for post-market surveillance and quality-related activities. Develop and deliver regulatory compliance training to internal teams. Collaborate with Quality, Clinical, Engineering, Manufacturing, and Commercial teams to ensure regulatory compliance throughout the product lifecycle. "What are the Mandatory skills and skill proficiencies required for this position?" Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related scientific/technical discipline, along with 12+ years of relevant industry experience. Minimum 5 years of experience in Regulatory Affairs and/or Quality within the medical device, healthcare, or life sciences industry. Minimum 2 years of direct Regulatory Affairs experience. Strong knowledge of U.S. FDA regulations and medical device regulatory requirements. Experience managing: Product Incident Reports (PIRs) Corrective and Preventive Actions (CAPAs) Product recalls and field corrective actions Audit and inspection support activities Experience using regulatory systems, databases, and documentation tools. Strong written and verbal communication skills"What are the Optional skills and skill proficiencies for this position?As mentioned in the JDPlease add the below to the comment section:Legal Name:Current Location: (City, State & Zip Code):Home location:Relocate:Bill Rate:CTH After 3 Months:Travelling Availability:Availability to Start:Phone/Mobile Number:Skype ID:Email Address:Visa Type:Visa Expiration Date:Hiring Status:Are you working directly with the contractor’s visa holder:If not indicate # of layers and names of the company:Indicate if the Candidate has worked in CG before and where:Ex-*** Employee:LinkedIn Account: (If available)Time slots for an interview:Contractor approved to share its resume to client:Skills summary:Resumes will be rejected for the following reasons: Different format Missing details in comments section Missing text box in the header Photo ID included containing personal information other than legal name and photoSoemia Pineda - ERM North AmericaTel.: +***"