Senior Regulatory Affairs Specialist
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Regulatory Affairs Specialist at Merit Medical determining regulatory pathways for medical device submissions. Collaborating with teams on U.S. and international regulatory requirements and submissions.
Responsibilities:
- Determines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
- Participates on various teams to define regulatory requirements of U.S. and international submissions, Technical Files or regulatory rationales.
- Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
- Prepares regulatory submissions to the FDA, the Notified Body and other regulatory authorities.
- Prepares IDEs and PMAs and assists with clinical trials when required.
- Interacts with various levels of management, external agencies and companies.
- Analyzes and makes recommendations regarding field complaints.
- Develops, maintains and analyzes department systems and provides training when needed.
- Remains current on developing regulations and revises systems as necessary.
- Participates in and assists with FDA facility inspections, Notified Body Audits and other inspections and audits as directed.
- Assists with supervision of department staff, as directed.
- Performs other related duties and tasks, as required.
Requirements:
- Education and/or experience equivalent to a Bachelor's Degree in a technical field such as the biological, physical, engineering or material science disciplines and six years of related industry experience.
- Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
- Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers.
- Self-motivated, self-directing, strong attention to detail and excellent time management skills.
- Strong interpersonal skills and the ability to communicate well – verbally and in writing – with others.
- Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.
Benefits:
- Medical/Dental & Other Insurances (eligible the first of month after 30 days)
- Low Cost Onsite Medical Clinic
- Two (2) Onsite Cafeterias
- Employee Garden | Gardening Classes
- 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
- 401K | Health Savings Account
Similar Jobs
Specialist, Regulatory and Pharmacovigilance Network
Specialist managing regulatory and pharmacovigilance deliverables for PrimeVigilance. Liaising with regulatory areas and completing PV deliverables based on established plans.
Regulatory Risk Support
Regulatory Risk Support role assisting the Regulatory Risk Division with BSA compliance and administrative tasks. Involves preparing reports, managing research, and supporting the Compliance department.
Federal Contracts & Compliance Manager
Federal Contracts & Compliance Manager overseeing federal contract administration and regulatory compliance. Managing GSA Schedule and advisory roles in protests and audits within Lynker Corporation.
Coordinator, Global Fire Life & Safety Compliance
Coordinator for Global Fire Life & Safety Compliance at Hyatt. Overseeing global safety program and ensuring compliance standards across properties.
Manager, Clinical Compliance
Manager of Clinical Compliance overseeing and expanding Eleanor Health’s clinical care compliance across multiple markets. Leading a team to ensure adherence to state regulations and accreditation standards.
Clinical Compliance Contractor – Contract to Hire
Clinical Compliance Contractor supporting compliance operations, licensure, and accreditation at Eleanor Health. Role requires independent work and expertise in healthcare compliance with a focus on behavioral health.
Senior Quality Compliance Manager
Senior Manager overseeing GMP/GDP inspections for a global biotech company. Leading quality compliance efforts and regulatory interactions to ensure operational excellence.
Senior Manager, Regulatory Strategy
Senior Manager/Associate Director of Regulatory Strategy for clinical development programs at Praxis Precision Medicines. Leading global regulatory strategies and lifecycle management in biotech/pharma.
Senior Specialist, Regulatory Operations
Senior Specialist leading regulatory operations for clinical trials at Care Access. Ensuring compliance with U.S. regulations and supporting site-level activities in a remote role.
US Regulatory Lead
US Regulatory Lead providing regulatory expertise for Amgen molecules. Planning and executing regulatory strategies in compliance with local regulations.
Government Compliance Manager
Government Compliance Manager at Workstreet guiding clients through federal cloud compliance frameworks. Leading teams in FedRAMP, GovRAMP, and NIST 800-53 authorization processes.
Regulatory Manager – Obesity, Related Conditions
Regulatory Manager at Amgen overseeing U.S. regulatory strategy and compliance for Obesity products. Leading clinical trial support and regulatory submissions for product licensing.
Global Regulatory Director Lead – Obesity & Related Conditions, Type II Diabetes
Director providing regulatory leadership for obesity and related conditions at Amgen. Developing global strategies and leading interactions with health authorities.
Compliance Lead
Compliance Lead overseeing end-to-end tax filing and compliance across multiple jurisdictions for a global trade infrastructure startup. Focus on accuracy and scalability with automation in processes.
IT & Compliance Manager
IT & Compliance Manager at LINK, overseeing IT operations and compliance with a focus on federal standards. Leading CMMC certification and managing cybersecurity initiatives in a remote setup.
Risk Management Consultant – GRC Practice
Risk Management Consultant at Artemis Connection helping clients build and mature enterprise risk programs. Focused on strategic, operational, regulatory, and reputational risks with an emphasis on cybersecurity.
Governance Consultant – GRC Practice
Governance Consultant enhancing compliance practices across sectors, assessing current governance, designing structures, and driving adoption. Client-facing role focusing on strategic decision-making in governance and risk.
Compliance Consultant – GRC Practice
Compliance Consultant delivering compliance assessments and advisory engagements across various frameworks for GRC practice. Managing client relationships and contributing to business development activities.
Senior Analyst, Corporate Compliance
Senior Analyst Corporate Compliance at CVS Health overseeing regulatory compliance for Aetna's commercial insurance business. Supporting risk assessments, compliance documentation, and business initiatives for regulatory impact.
Manager, Coding Compliance – Orthopedic Surgery
Manager Coding Compliance tasked with ensuring proper charge capture and coding compliance in orthopedic surgery operations. Supervising staff and interacting with faculty for revenue maximization and compliance.