Regulatory Affairs Specialist Job at Polysciences, Inc., Warrington, PA

S2tLd2c0aUhlakRlelBPb0d3a0UydWRDS2c9PQ==
  • Polysciences, Inc.
  • Warrington, PA

Job Description

The Regulatory Affairs Specialist is responsible for ensuring compliance with applicable regulatory requirements, including 21 CFR Part 820 GMP, ISO 13485:2016, and other international standards. This role will support product development, registration, and post-market activities to ensure Polysciences, Inc. & Kyfora Bio LLC products meet all regulatory, safety, compliance and quality requirements. This position is 100% onsite

Essential Functions:

Provide regulatory guidance during new product design and development to ensure compliance with applicable standards and regulations.

  • Prepare, review, and submit regulatory documentation for Drug Master Files, product approvals, registrations, and renewals (e.g., FDA submissions).
  • Maintain compliance with 21 CFR Part 820 GMP, ISO 13485:2016 , and other relevant quality system requirements.
  • Support external audits, including supplier audits, customer audits, FDA inspections and Notified Body audits.
  • Conducts Internal Audits and maintains the Internal Audit system.
  • Ensure product labeling, packaging, and promotional materials meet regulatory requirements.
  • Monitor and assess regulatory changes, guiding cross-functional teams on potential impacts.
  • Collaborate with R&D, Quality, Sales, Marketing, and Manufacturing and other applicable departments to ensure regulatory compliance throughout the product lifecycle.
  • Participate in risk management activities, including design controls, change control, and NC/CAPA processes.
  • Maintain regulatory records, databases, and documentation to support audits and inspections.
  • Conduct regulatory gap assessments on products and implement necessary actions to address the identified gaps.
  • Quality Agreement review and interpretation for QA Management approval.

Qualifications

Education Required : Bachelor's Degree

Certification(s):

Auditor training required.

Lead Auditor Certification preferred .

Regulatory Affairs Certification (RAC) or Regulatory Compliance Certification (RCC) preferred.

Computer Skills Required:

Proficiency with document management software and Microsoft Office Suite.

Preferred experience with Enterprise Resource Planning (ERP) systems for tracking suppliers, materials, and customer complaints.

Preferred experience with electronic QMS systems for tracking and reviewing documents, training, quality issues, CAPA, effectiveness checks, and change controls.

Other qualifications:

  • 3+ years of regulatory affairs experience in a medical device or pharmaceutical manufacturing environment .
  • In-depth knowledge of 21 CFR Part 820 and ISO 13485:2016 .
  • Knowledge of 21 CFR Part 210,211 requirements preferred .
  • Strong understanding of design controls, risk management, and product lifecycle requirements.
  • Excellent organizational, communication, and technical writing skills.
  • Ability to work cross-functionally and manage multiple priorities in a fast-paced environment.
  • Familiarity with REACH, EU MDR, MDSAP, and international regulatory pathways is a plus.
  • Experience with Good Manufacturing Practices (GMP)
  • Strong analytical and problem-solving abilities.
  • Highly organized and detail-oriented, with the ability to manage multiple tasks, systems and projects simultaneously.
  • Experience with SAP preferred.
  • Strong written and verbal communication skills to interact effectively with various departments, such as Quality, Operations, and Engineering.
  • Experience with audit preparedness and support during internal and external audits.

Job Tags

Permanent employment, Work at office,

Similar Jobs

Marriott

Housekeeper Job at Marriott

 ...Information Job Number 25177925 Job Category Housekeeping & Laundry Location Sheraton Boston Hotel, 39 Dalton Street, Boston, Massachusetts, United...  ...school diploma or G.E.D. equivalent. Related Work Experience: No related work experience. Supervisory... 

Ardent Health

Security Officer Job at Ardent Health

Overview Join our team as a full-time, Security Officer in Cushing, OK. Why Join Us? Thrive in a People-First Environment and Make Healthcare Better ~ Thrive: We empower our team with career growth opportunities, tuition assistance , and resources ...

Weirton Management Group, Inc.

FedEx Linehaul Class A Team Driver Job at Weirton Management Group, Inc.

 ...We need TEAM DRIVERS but WE WILL ALSO HAVE SOLO & LOCAL RUNS STARTING 3rd WEEK OF NOVEMBER . Job Details: ~ Based out of Rialto/Bloomington Area. ~ Must be willing to do TEAM driving. ~5 days OTR/2 days home. ~ Typical run can range from 4800 to over 600... 

Community Medical and Dental Care Inc

Dental Assistant Job at Community Medical and Dental Care Inc

 ...A growing health center in Rockland County, NY is seeking a full-time Dental Assistant to join our dynamic and fast-paced dental team. We are looking for an experienced, compassionate professional who is committed to providing high-quality patient care and supporting... 

Carle Health

Certified Medical Assistant - Maternal Fetal Medicine Job at Carle Health

 ...support duties in a medical practice to assist medical and/or nursing staff in the examination and treatment of patients and...  ...including, but not limited to, patient check in or check out, prior authorizations, scheduling appointments, verification of benefits, and coordination...