Position Summary:

The Regulatory Affairs Specialist I performs product registrations and acts as the company representative with the applicable regulatory authorities. The position researches regulatory requirements and options for regulatory submissions, approval pathways and compliance activities.  The position works with project teams to implement regulatory affairs strategies with the goal of ensuring timely product marketing authorizations. The Regulatory Affairs Specialist I reviews labeling and marketing materials for regulatory compliance. Additionally, the position supports Quality System compliance by reviewing design documents and implementing compliance mechanisms for new and emerging regulations, standards, and regulatory guidance. The Regulatory Affairs Specialist I ensures information and data in support of marketing authorizations is complete and accurate. This position collaborates with personnel with the business unit and company.

Key Accountabilities

• 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. Assemble and 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. Coordinate with internal personnel to resolve potential regulatory issues, deficiencies, and questions from regulatory agencies.
• Regulatory Intelligence: Acquire, research, 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 (SMEs). Assist in the development of plans for meeting and complying with new regulations, guidance, and standards. Assist in developing strategy for complying with new and emerging regulations, guidance, and standards.
• Regulatory Strategic and Tactical Management. Support the creation of regulatory plans to document regulatory strategies to support product improvements and new product development. Implement regulatory strategies and tactics to accomplish company goals and initiatives.
• Quality Management System Support: Support the creation and update of regulatory procedures. Maintain procedures and work instructions related to Regulatory processes. Support Regulatory function and assist other departments in audit and inspection preparation.
• As needed, provide assessment of new external standards and applicability to Werfen AID.
• 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
• R&D
• Affiliates
• Other Werfen Manufacturer’s Regulatory functions
• Regulatory Agencies (U.S. and International)
• Professional and Technical Organizations

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. 

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.
• Five (5) years of work experience in in vitro diagnostic (IVD) or medical device (MD) industry of which three (3) should be Regulatory.
• Experience in regulatory submissions including 510(k) and notified body technical documentation, preferred.
• Experience in international registrations, required.
• Project management experience, preferred.

Skills & Capabilities:

• Working knowledge of in vitro diagnostics regulations, guidances, and standards for obtaining domestic and international marketing authorizations and post-market vigilance.
• Working knowledge of regulatory intelligence tools and methods along with ability to interpret and apply regulations. Working knowledge of electronic publishing/file management system.
• Advanced skills in verbal and written communication including proofreading, scientific writing, presenting persuasive arguments in a positive tone, and presentation to various organizational levels.
• Working 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.
• Working ability to develop proactive and creative approaches to problem-solving including creating regulatory strategies that balance short and long-term objectives while adhering to timelines.
• Working 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 $90,000- $115,000 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.