Global Regulatory Affairs Specialist

Company: Puritan Medical Products
Location: Falmouth
Posted on: April 2, 2021

Job Description:

ALERT: Tremendous demand for COVID-19 testing supplies may lead to delays in response times, orders and fulfillment for many of our products. We're committed to your needs and are working virtually nonstop to meet them. Learn More Senior Global Regulatory Affairs Specialist Job Summary: The Senior Global Regulatory Affairs Specialist will be responsible for pre-market and post-market Regulatory activities to support market clearance/approvals and maintain Regulatory compliance throughout the life cycle of Puritan products. You will be responsible for establishing a foundation toward developing a world class Quality & Regulatory Team. Puritan will rely on you to lead and accomplish our critical and long-term goals. Duties/Responsibilities:

• Responsible for Technical File preparation and maintenance to meet jurisdictional requirements with focus on EU 2017/745 Medical Device Regulation (MDR) requirements.
• Support regulatory strategies to achieve desired domestic and international clearance/approval and maintenance of approvals, licenses, and authorizations for existing markets.
• Prepares and updates "Declarations of Conformity" as per EU MDD and EU MDR.
• Maintain applicable databases as required ensure regulatory compliance.
• Perform Labelling reviews to assure compliance with product claims, and applicable regulatory requirements.
• Support the Adverse Event, Vigilance, MDR, and Post-Market Surveillance program and submit timely reports to the applicable regulatory agency.
• Perform Recall/Field Safety Corrective Action related activities, as needed.
• Assist with Post Market Clinical Follow-up (PMCF), Clinical Evaluation Report (CER), Periodic Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP) that meet Post-Market Surveillance reporting requirements.
• Responsible for the development, implementation, and maintenance of Design Control Program.
• Responsible for the development, implementation, and maintenance of various Regulatory Affairs and Regulatory Compliance related procedures and continually improve processes.
• Responsible for the development, implementation of a State-of-the-Art Risk Management Program according to ISO 14971:2019.
• Perform Product Risk Reviews and maintain Risk Management Files.
• Maintains collaborative relationships with external parties including Regulators, Suppliers, and Economic Operators. Education and Experience:
  • Bachelor's degree and 3 or more years of experience in Quality Assurance / Regulatory Compliance is required.
  • Experience facilitating group meetings, managing conflict, and assigning action items and meeting strict timelines.
  • Knowledge of laws/regulations, standards, and guidance documents pertaining to the medical device industry (i.e., ISO 13485, ISO 14971, MDSAP, MDD/IVDD, MDR/IVDR, FDA Part 820 & 803).
  • Strong computer skills and previous application of Microsoft Excel, Word, PowerPoint, Project, Visio, database management, statistical analysis and reporting packages. Physical Requirements:
    • Must be able and willing to work in a fast-paced environment.
    • Prolonged periods sitting at a desk and working on a computer.
    • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
    • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work requires operation of a computer. Location: This is a remote / work-from-home position. Puritan's main operation is in Guildford, ME with 2 additional manufacturing facilities in Pittsfield, ME and a sales office in Falmouth, ME. Hardwood - Puritan is An Equal Opportunity/Affirmative Action Employer. All qualified applicants and employees for hiring, placement and advancement will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or military status, age, or any other federally protected class. Employment Application Process Click below to download and fill out our digital application. Once you've completed the employment application form, submit your application using the form below.

Keywords: Puritan Medical Products, New Bedford , Global Regulatory Affairs Specialist, Other , Falmouth, Massachusetts