Job Abstract

Job ID

2023-6590

Type

Regular Full-Time

Shift

1st

Category

Quality Assurance/Regulatory Affairs

Werfen

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Position Summary:

The Staff Regulatory Specialist performs product registrations and act as the company representative with the applicable regulatory authorities. The position works with project teams to implement regulatory affairs strategies with the goal of ensuring timely product marketing authorizations. The Staff Regulatory Specialist reviews labeling and marketing materials for regulatory compliance. Additionally, the position develops Regulatory strategies for new product development and design changes while representing regulatory interest on product development teams. The Staff Regulatory Specialist advises on the implementation of compliance mechanisms for new and emerging regulations, standards, and regulatory guidances. This position collaborates with personnel with the business unit and company.

Key Accountabilities

• Design Control: Is Regulatory lead on cross-functional product development teams. Provide team with strategic and tactical guidance regarding global regulatory requirements to support product marketing authorizations. Review product design and change documentation, performs regulatory assessments, and implements required regulatory actions.
• Regulatory Projects: Independently lead multiple long-term projects. Interact with supervisor as required on activities, issues, or turning points. Models effective team dynamics behavior. Encourages and empowers others to achieve project outcomes. Provide training and guidance to junior members of the team.
• Marketing Authorizations: Assess and document assessment of regulatory marketing requirements for global markets. Schedule milestones, generate supporting documentation, and provide deliverables for assigned regulatory applications and renewals according to governing rules governing rules and regulations of the affected geographies. Perform or ensure activities to obtain global market authorization in domestic and international geographies including submissions, registrations, apostilles, declarations, license applications, attestations, certifications, design dossiers, and technical documentation, export certificates, and device listings. Maintain product technical documentation and ongoing activities related to compliance with global regulatory directives and regulations. Create records in central repository of market authorization deliverables and responses. Represent company in interactions and communications with regulatory authorities to obtain timely market authorizations. Coordinate with internal personnel to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.
• Regulatory Intelligence: Acquire and maintain current knowledge of applicable regulatory requirements and scientific issues in the marketed geographies. Monitor and analyze the development of new and emerging regulations, guidance, and standards in marketed geographies. Coordinate evaluation of new and emerging standards with Subject Matter Experts. Assist in the development of plans for meeting and complying with new regulations, guidance, and standards. Develop strategy for complying with new and emerging regulations, guidance, and standards.
• Regulatory Strategic and Tactical Management: Assist Regulatory management with development of strategic and tactical options for accomplishing company goals and initiatives. Implement regulatory strategies and tactics. Manage regulatory consultants when engaged to assist with goals.
• Labeling, Advertising, and Promotion Review: Review and approve labeling for compliance to labeling requirements, including content, format, and regulatory registration impact, etc. Provide regulatory review and approval for product marketing colletrial.
• Quality Management System Support: Assist in the education and broadening the regulatory knowledge within the Werfen teams. Author, implement, and maintain departmental procedures, work instructions, and templates associated with the regulatory activities. Maintain procedures and work instructions related to Regulatory processes. Support Regulatory function and assist other departments in audit and inspection preparation.
  • Comply with all aplicable standard operating procedures (SOPs), QSR regulations, as well as aplicable Environmental Health & Safety (EHS), Human Resources and other regulatory and administrative policies.
  • Comply with all aplicable standard operating procedures (SOPs), QSR regulations, as well as aplicable Environmental Health & Safety (EHS), Human Resources and other regulatory and administrative policies.
  • Reflect Werfen Values in the quality of work and in working relationships.

Networking/Key Relationships:

• Quality Teams
• R&D Teams
• Affiliates
• Other Werfen Manufacturer’s Regulatory Teams
• Regulatory Agencies (Domestic and International)
• Professional and Technical Organizations

Minimum Knowledge & Experience Required for the Position:

• Bachelor’s degree in a life science, engineering, or equivalent required. Advanced degree preferred.
• Regulatory Affairs Certification preferred.
• Ten (10) years of work experience in in vitro diagnostic (IVD) or medical device (MD) industry of which five (7) should be Regulatory.
• Experience in regulatory submissions including 510(k) and notified body technical documentation required.
• Experience in international registrations required.
• Project management experience preferred.

Skills & Capabilities:

• Advanced knowledge of in vitro diagnostics regulations, guidances, and standards for obtaining domestic and international marketing authorizations and post-market vigilance.
• Advanced knowledge knowledge of regulatory intelligence tools and methods, with ability to interpret and apply regulations. Knowledge of electronic publishing/file management system.
• Advanced verbal and written communication skills including proofreading, scientific writing, presenting positive presusive arguments, and presentation to various organizational levels.
• Advanced skills in leadership, influence, and negotiation with the ability to build collaborative relationships.
• Advanced ability to organize and complete multiple assignments in a fast-paced environment in a timely, accurate manner as a team member and/or as an individual contributor.
• Advanced analytical skills with ability to develop proactive and creative approaches to problem-solving including creating regulatory strategies that balance short and long-term objectives.
• Advanced ability to understand and interpret complex scientific topics as it relates to regulatory requirements, regulatory intelligence, and policy and strategy.

Travel Requirements:

• Limited travel required.

The salary range for this position is currently $140,000-$185,000 annual. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget and/or other business and organizational needs.

If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com