מדעים/ביוטק

Regulatory Affairs Specialist

496866

תאריך עדכון

01/03/2021

תיאור המשרה

 Regulatory Affairs Specialist with a fast growing, global, Class II US Class III (EU) medical device company, responsible for working internationally with cross-functional teams to support regulatory license/registrations for commercialized devices under the direction of senior RA personnel. Independently organize and maintain device regulatory information and documentation to ensure consistency and regulatory compliance.

Responsibilities:

• Conducts 510(k) and CE Mark impact assessments for product changes.
• Co-authors 510(k) submissions and significant change notifications for product changes with moderate business impact.
• Maintains letter-to-file history and updates technical documentation as needed in support of product changes/life cycle management and post-market data.
• Monitors and coordinates maintenance of global product registrations, product regulatory certificates, business licenses (e.g. CDPH), and establishment registrations.
• Maintains regulatory databases such as FURLS, GUDID and EUDAMED to ensure data accuracy.
•Ensures service continuity with key 3rd party regulatory services (e.g. contract regulatory
representatives, standards maintenance service, etc.)
• Monitors product shipment eligibility based on market clearance/approvals as communicated by senior RA personnel.
• Coordinates notaries, legalizations, and apostilles in support of product registrations as needed.
•Serves as the department archivist following document retention guidelines for key RA documentation.
• Helps identify opportunities and implement process efficiencies.
• Supports interdepartmental information requests.
• Performs other regulatory-related duties as assigned.

Qualifications:

• BA or BS degree required; science, technology, engineering and technology background highly
preferred.
• Minimum 2 years of previous experience working in a regulated industry required; experience in the medical device field highly preferred.
• Minimum 2 year of regulatory affairs or regulatory compliance experience required.
• Familiarity with medical device regulations and standards (e.g. 21 CFR 820.30, ISO 13485, IEC 62304, ISO 14971, ISO 10993, etc.) preferred.
• Strong attention to detail, interpersonal skills, reading comprehension, organizational skills, multi-
tasking, and critical thinking/problem-solving skills required.
• Experience with MS Word, MS Excel, and Adobe PDF to compile and publish documents required.
• Strong written and oral communication skills.
Compile and maintain regulatory documentation databases or systems.
Coordinate efforts associated with the preparation of regulatory documents or submissions.
Analyze product complaints and make recommendations regarding their reportabsility.
Develop or conduct employee regulatory training.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance
documents.

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