Job Summary

The Staff Regulatory Specialist performs product registrations and act as the company representative with the applicable regulatory authorities. The Staff Regulatory specialist represents Regulatory Affairs on product development teams, partners with product development teams and global partners to develop and implement Regulatory plans, prepares and submits Regulatory submissions to obtain timely product marketing authorizations. The Staff Regulatory Specialist conducts regulatory impact assessments for product and process changes. The Staff Regulatory Specialist reviews labeling and marketing materials for regulatory compliance. The Staff Regulatory Specialist evaluates new and emerging regulations, standards, and regulatory guidances to assess impact to products and processes.

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 manager 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 Promotional Materials 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 applicable standard operating procedures (SOPs), QSR regulations, as well as applicable Environmental Health & Safety (EHS), Human Resources and other regulatory and administrative policies. Comply with all applicable standard operating procedures (SOPs), QSR regulations, as well as applicable 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:

• Bachelor’s degree in a life science, engineering, or equivalent required. Advanced degree preferred.
• Minimum of 6 years of experience in Regulatory Affairs, of which a minimum of 4 years must be in IVD Regulatory Affairs.
• Regulatory Affairs Certification preferred.
• Experience in regulatory submissions including 510(k) and IVDR technical documentation required.
• Experience in international registrations preferred.
• 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 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 persuasive 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.

Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day.  Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment.  May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch.  Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.  May occasionally have to lift and/or move up to 25 pounds.  The noise level in the work environment will vary but is usually moderate. 

Other Duties and Acknowledgement:

The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. Note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of employment with Werfen.

The salary range for this position is currently $120,000- $175,000 annually. 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.