The Regulatory Affairs Specialist is responsible for the coordination and the preparation of documents/packages for the device section of regulatory submissions, including Master Access Files (MAF) and STED. This individual will create all types of regulatory documents in a clear and concise format, review and evaluate technical and scientific data, review technical reports required for support of company’s products, and utilize electronic editing skills in the preparation and reviewing of diverse regulatory documents.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsibilities include, but are not limited to:
- Prepare FDA and STED submissions for new products and existing product changes as required to ensure timely approval for market release and in accordance with applicable regulations, standards, and guidance
- Maintain regulatory affairs product files to support compliance with requirements and standards
- Interpret, execute, and recommend modification to internal guidelines, work instructions, procedures
- Monitor industry and regulatory trends and develop strategy and provide guidance related to such trends
- Participate as an active team member of project teams as required
- Support post-market activities including, but not limited to regulatory assessment of change orders, reports, and records
- Author or update Regulatory standard operating procedures (SOP), work instructions, or other policies
- Support senior regulatory personnel in product development deliverables
- Support senior personnel in review of changes in standards, regulations, guidance, and events in the areas of medical devices and drug / device combination products
- Collaborate closely with Antares cross-functional stakeholders to achieve enterprise business objectives
- Determine and define regulatory requirements to stakeholders throughout the company. Review and determine regulatory implications of change orders on product, design, manufacturing and/or other documentation
- Participate on project teams and business group teams to provide regulatory support and input. Provide recommendations for how to overcome regulatory barriers and resolve any conflicts within teams as to the need and importance of regulatory requirements
- Facilitate organizational cohesiveness with the Antares regulatory philosophy and improve regulatory and compliance position and consistency of the Antares businesses
- Assist in various projects as assigned
CUSTOMERS OR CLIENTS:
- Senior Management
- Minnesota Design Engineers
- Minnesota Quality Team
- Minnesota Manufacturing Engineers
- External Partners and Regulatory Authorities
EDUCATIONAL REQUIREMENTS(degree, license, certification:
- Bachelor’s Degree in a scientific, engineering, pharmacy, or related scientific discipline
- RAC preferred, not required
YEARS OF EXPERIENCE:
- 3+ years of progressive experience in domestic/international regulatory or quality, and/or regulatory compliance utilizing design control systems within the medical device industry
- Experience with product registration requirements of U.S. FDA (Class II) and/or combination products
- Experience with ISO 13485, FDA QSR, cGMP, EU MDR
OTHER SKILLS AND ABILITIES:
- Ability to build relationships across functional boundaries at multiple levels
- Strong technical, analytical, and problem-solving skills
- General office skills (e.g. word processing, spreadsheets, databases, online research)
- Adaptability/Flexibility - Adapts to change, is open to new ideas, takes on new responsibilities, handles pressure, adjusts plans to meet changing needs.
- Listening Skills - Listens attentively to others, asks clarifying questions, actively listens, stays open to other viewpoints, manages distractions and interruptions.
- Quality Work - Is attentive to detail and accuracy, is committed to excellence, looks for improvements continuously, monitors quality levels, finds root cause of quality problems, owns/acts on quality problems.
- Research/Information Finding - Finds needed data through known sources; has good contacts or source knowledge; uses resourcefulness to tap as-yet-unknown sources; identifies, sorts, and categorizes source materials to deliver most pertinent information.
- Ability to contribute to multiple projects from a regulatory affairs perspective
- Ability to multitask and prioritize
- Strong written and verbal communication skills, especially when dealing with regulatory agencies or certification bodies
- Ability to explain and resolve differences in interpretation of standards, regulations, and regulatory/compliance requirements
We are not accepting solicitations from Recruiters or Consultants at this time.
APPLY TO: Careers@Antarespharma.com