- 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 for China NMPA and Japan PMDA.
- 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 IL personnel on 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.
- Effective decision maker
- Excellent communication skills to facility agreement/coordination between different groups/departments
- Knowledge in NMPA and PMDA medical device regulations
- Act as an advisor and educator to Company on NMPA and PMDA regulations and requirements
- Ability to prioritize and plan work with minimal supervision in a fast-pace environment.
- Minimum of 5-years' experience in the medical device industry (in-vitro diagnostics a plus) or equivalent experience
- Experience in the preparation of technical submission to obtain NMPA and /or PMDA regulatory approval.
- Demonstrated understanding of NMPA Decree 680 along with its lower-level regulations pertaining to the QMS and other general product registration matters, as well as CFR 21 820/ISO 13485 requirements.
- Additional skills/knowledge:
- Effective verbal and written communication in individual and group settings
- Excellent analytical and strategic thinking skills
- Strong project management skill
- Cross-cultural project experience a plus
- RAC certification is a big plus
- Language fluency: English and Chinese essential
- No
- Available to travel domestically and internationally as needed. <10% per year.
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Senior Regulatory Affairs Specialist - Bedford, United States - Werfen
Description
Overview
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 China NMPA and Japan PMDA registration and renewal activities for IL-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 regulatory compliance.
Responsibilities
Key Accountabilities:
Responsible to participate on design and risk management teams (both Hemostasis and Acute Care) as the regulatory representative and provide guidance on China NMPA and Japan PMDA requirements, including:
Networking/Key relationships:
To be determined based on department needs. This individual needs to develop relationships working with the domestic and international Quality, Regulatory, R&D, Marketing and Operations teams.
Skills & Capabilities:
Qualifications
Minimum Knowledge & Experience required for the position
Education: Bachelor's degree in engineering or science, advanced degree
Experience:
International Mobility: Required:
Travel Requirements:
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 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.
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