Regulatory Affairs Specialist III

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

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.

Position Summary:

This position is responsible for ensuring that premarket and/or postmarket regulatory activities for digital health products follow applicable domestic and international regulations and guidance. Working independently, with guidance from management or senior regulatory staff, the position will participate in crossfunctional software development meetings; prepare softwarespecific submission and registration documentation; assess and document software changes, cybersecurity impacts, and algorithm updates. This role is technically focused and requires advanced skills in analyzing software medical device products and regulations, reviewing verification/validation protocols and reports, evaluating risk management documentation, authoring regulatory documents for agile/iterative development environments, and promoting compliance with global digital health requirements.

Key Accountabilities

Essential Functions:

• Advise and direct teams on regulatory requirements related to new product development or significant changes
• Ensure test protocols and reports for new products or significant product changes meet regulatory requirements for intended market(s)
• Author regulatory plans as regulatory lead for new products or significant product changes, including interfacing with country market approval holders to confirm local regulatory requirements
• Act as lead on regulatory filings for market clearance, licensing, registration, and legalization, both domestic and international
• Review and approve labeling and marketing materials associated to regulatory filings
• Advise and direct teams on regulatory requirements for on-market product changes
• Author regulatory determinations as regulatory lead for on-market product changes, including interfacing with country market approval holders to confirm local regulatory requirements
• Ensure company site and device registrations are compliant with applicable domestic and international regulations
• Review and approve changes orders for product labeling changes, regulatory procedure changes and marketing communications as required
• Increase working knowledge of regulations, standards, company SOPs and tools
• Assist in interactions regarding regulatory affairs with all functional areas of the company as required including senior management
• Assist in tracking standards, regulations and all applicable requirements
• Other duties as assigned

Secondary Functions:

• Assesses regulatory gaps and take the appropriate corrective actions, as needed
• Supports internal and external audit as required
• Participates in regulatory improvement projects as required

Budget Managed (if applicable)

• N/A

Internal Networking/Key Relationships

To be determined based on department needs, to include interactions such as:

• Work closely with other functions and across facilities to generate regulatory documentation in alignment with domestic and international requirements
• Ability to negotiate and influence others in establishing direction toward improved regulatory and enhanced compliance
• Ability to effectively communicate regulatory requirements to a broad population of constituents

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and capabilities:

• Ability to read and interpret domestic and international regulatory/quality standards related to our products
• Working knowledge of IL products, technology, and regulatory requirements, including impact on customers and patient requirements
• Demonstrates judgment commensurate with experience regarding application of regulatory requirements to data review, protocols, reports, design changes, etc. to ensure compliance and achieve business objectives
• Recognition of when to escalate issues to management or consult with more senior staff members.

Competencies:

• Attention to Detail: Ability to pay close attention to detail is required
• Accuracy: Work is accurate and complete
• Performance Standards: Demonstrated ability to meet department goals
• Communication: Excellent written, verbal and presentation skills
• Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality
• Multi-Tasking: Ability to manage multiple priorities, and support changing business needs
• Collaboration: Ability to work within a team to bring best solutions to the team or customer
• Independence: self-motivated-works under minimal supervision
• Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
• Takes Initiative: Serves as a role model for "Quality First" by continuously improving on what matters most to customers
• Problem Solving: Promptly and effectively handles issues and problems
• Decision Making: Makes decisions based on data and risk determination

Minimum Knowledge & Experience Required for the Position:

Education:

• Bachelor's degree or higher, preferably in science and/or regulatory

Experience:

• Minimum of 5-years' experience in medical devices, in vitro diagnostics, pharmaceuticals or clinical laboratory or 2 years' experience with an advanced degree

Additional Skills/Knowledge:

• Duties necessitate broad and thorough knowledge of regulatory and compliance requirements, including domestic and international regulations
• Understanding of the application of regulatory principles in the areas of pre-market or post-market compliance
• Knowledge of FDA, ISO, MDSAP and international country regulations
• Knowledge of design control requirements and understanding of GMP
• Language: English

International Mobility:

• Required: No

Travel Requirements:

• <10% of time

The annual base salary range for this role is currently $105K to $130K. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

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

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com