- Must be Bilingual in English and Mandarin
- Must be able to commit to going on site 3 days a week
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Senior Regulatory Affairs Specialist - Bedford, United States - Actalent
Description
MUST HAVES:
Responsibilities
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:
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 requirements and priorities.
Qualifications
Minimum Knowledge & Experience required for the position
Education: Bachelor's degree in engineering or science, advanced degree
Experience:
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
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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