Regulatory Affairs Specialist II

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:

Responsible for domestic and/or international registration and renewal activities for Werfen-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review and other regulatory work required to maintain domestic and international compliance.

Key Accountabilities

Essential Functions:

Responsible to participate on design and risk management teams in the Hemostasis group as the Regulatory representative and provide guidance on domestic and international requirements, including:

• Author and sign Regulatory Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications as part of design input.
• Author and sign Regulatory Determinations on worldwide registration impact for significant product modifications as a design output.
• Prepare new product registration packages and technical files (e.g. CE Mark, 510ks, Canadian licenses).
• Provide support materials for Milan Regulatory for other country registrations.
• Assist with product renewal packages to maintain country registrations.
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Identify and screen historical data or reports that could be incorporated into future regulatory submissions to assure compliance with current scientific and regulatory standards.
• Responsible for maintenance of Regulatory Database in SAP.
• Responsible to review marketing and sign promotional materials for signature by management (as appropriate).
• Responsible to review and sign labeling and Change Orders (as appropriate).
• Educate and train Werfen personnel on domestic and international country registration and labeling requirements to ensure that during product development, their requirements are understood and incorporated.
• Other assignments related to RA/QA to support Werfen requirements and priorities

Budget Managed (if applicable):

• N/A

Internal Networking/Key Relationships:

• To be determined based on department needs

Skills & Capabilities:

• Requires superior communication skills (verbal and written)
• Proficiency with standard software (Word, Excel, PowerPoint, Adobe Acrobat etc.)
• Hands on experience working in a regulated environemnt following QMS systems.
• Previous experience and familiary with In vitro Diagnostics, software in medical device strongly preferred.
• Experience with SAP is a plus.

Minimum Knowledge & Experience Required for the Position:

• Requires a Bachelor degree, preferably in life sciences or engineering familiarity with ISO 13485 and 14971 preferred.
• Two years minimum experience in the Medical Device Industry or other highly regulated environment.

International Mobility: Required:

• No

Travel Requirements:

• Must be available to travel domestically and internationally as needed.
• <10% per year.

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