Job Information
About the Position
Introduction
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.
Overview
Position Summary:
Responsible to lead domestic and/or international registration and renewal activities for Werfen-labeled products. Related duties include participation on design teams, authoring of regulatory assessments for both new products and product modifications, documentation of regulatory impact from device modifications, establishment and maintenance of Technical Files, labeling I advertising review and other regulatory work required to maintain domestic and international compliance.
Responsibilities
Key Accountabilities
Essential Functions:
Responsible to participate on design teams (both Hemostasis and Acute Care Diagnostics) as the Regulatory representative and provide guidance on domestic and international requirements, including:
- Author Regulatory Assessments I Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications as part of design input.
- Author 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, CFDA registration materials, Japan Shonin information).
- Prepare support materials for Milan Regulatory for other country registrations (e.g. Australia, Korea, Latin America).
- Prepare product renewal packages to maintain country registrations.
- Responsible for the updating of Technical Files to ensure compliance.
- Responsible for maintenance of Regulatory Database in SAP.
- Responsible to review and approve Marketing promotional materials as determined by workload.
- Responsible to review and approve labeling and Change Orders as determined by workload.
- 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:
- Proficiency with standard software (Word, Excel, PowerPoint, etc.).
- Experience with SAP is a plus.
- Requires superior communication skills (verbal and written)
Qualifications
Minimum Knowledge & Experience Required for the Position:
- Requires a Bachelor degree, preferably in Life Sciences
- Minimum of 5 years of experience in the Medical Device Industry or other highly regulated environment with experience in domestic and/or international product registrations (e.g. FDA 51 Ok, Canadian licenses, CE mark, CFDA registration)
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
