Regulatory Affairs Specialist

Company: Johnson Service Group
Location: Telford
Posted on: September 20, 2022

Job Description:

JSG Contact: Allen Mudalel

Office:

Johnson Service Group (JSG) is currently looking for a Principal Regulatory Affairs Specialist with 510k's experience. This is a direct hire opportunity with a world leading manufacturer of Medical Devices in the Souderton PA area. This is a hybrid opportunity that could possibly be remote.

Salary $130k range with 12% bonus

The candidate will be writing 510K's and MDR Compliance experience is a plus. This position is supporting existing product and would be more maintenance related.

Responsibilities:

Leads the development and internal review of regulatory strategies and ensures that registration documentation for development projects are appropriately submitted in alignment with timeline expectations. This is achieved by;

Evaluating the regulatory environment throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) and

Helping to train stakeholders on current and new regulatory requirements to ensure product compliance

Manages and maintains worldwide country registrations and regulatory databases for SPP product portfolio. Reviews US and international standards and regulations for applicability to the Draeger product portfolio.

Evaluates impact of product changes to regulatory submissions worldwide, documenting regulatory decisions and communication/actions required for impacted regions.

Manages requests from regions and countries, provides responses and requested documentation (CFG's, certifications, document legalization, etc.) in a timely manner.

Collaborates with parties such as EU notified body officials, consultants, and government agencies including the FDA in support of product approvals and audits.

Reviews, approves and provides guidance for labeling and advertising. Ensure proper facility registrations and device listings for DMSI with appropriate regulatory agencies.

Education:

BS degree in a scientific discipline, preferably in the Life Science, Biomedical, Mechanical engineering or the equivalent in education, training and experience.

Experience:

8-12 years of regulatory experience in the Medical Device Industry is required. Experience in preparing and submitting Class II medical device marketing applications to regulatory agencies

Special Competencies or Certifications:

Regulatory Affairs Certification (RAC) a plus

In-depth knowledge of U.S. and International regulatory requirements for medical devices

Proven record of supporting project teams

Good Microsoft application skills

Excellent written and oral communication skills

In-depth knowledge of current ISO 9001, ISO 13485, CMDR SOR/98-282, MDD 93/42/EEC, J-GMP and 21 CFR Part 820

Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with over 35 years of experience investing in people and companies.

Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law


Please email resume to Allen Mudalel

Job Requirements:

• Support regulatory compliance and submissions
• Filing documents related to regulatory submissions
• Ensure compliance to existing regulatory submissions
• Preparing regulatory documents and/or submissions
• Submit regulatory applications and internal regulatory file documentation
• Verify compliance with regulatory requirements
• Ensure compliance with regulatory requirements
• Assure compliance of regulatory files
• Providing regulatory and compliance guidance
• Prepare submissions and reports for regulatory agencies
• Ensure compliance to regulatory standards
• Support and ensure regulatory compliance
• Discuss regulatory issues and submission requirements
• Formulate or implement regulatory affairs policies and procedures to ensure regulatory compliance
• Assisting regulatory team in developing regulatory strategy to ensure high quality and on-time regulatory submissions
• Maintain regulatory records for regulatory activities and applications
• Prepare regulatory document submissions and timely submit
• Review of regulatory quality documents
• Compile and maintain appropriate technical documents for regulatory submissions
• Assure global regulatory compliance of company products

Keywords: Johnson Service Group, Bethlehem , Regulatory Affairs Specialist, Other , Telford, Pennsylvania