Illumina ऐसी जीनोमिक तकनीकें विकसित करती है, जो शोधकर्ताओं और चिकित्सकों को आनुवंशिक विविधता का अध्ययन करने तथा स्वास्थ्य सेवा और जीवन विज्ञान के विभिन्न क्षेत्रों में जीनोमिक जानकारी का उपयोग करने में मदद करती हैं। इसके उत्पाद पोर्टफोलियो में नेक्स्ट-जेनरेशन सिक्वेंसिंग सिस्टम, माइक्रोएरे प्लेटफ़ॉर्म, लाइब्रेरी प्रिपरेशन किट, बायोइन्फॉर्मेटिक्स सॉफ़्टवेयर और एकीकृत जीनोमिक समाधान शामिल हैं। ये उपकरण कैंसर अनुसंधान, प्रजनन स्वास्थ्य और आनुवंशिक रोगों का पता लगाने जैसे क्षेत्रों में काम को सहयोग देते हैं और खोज तथा सटीक चिकित्सा को आगे बढ़ाने में मदद करते हैं।
Senior Regulatory Affairs Specialist, Recall and Post-Market Compliance
Senior regulatory affairs specialist at Illumina focused on post-market compliance for genomic diagnostics. Responsibilities include recalls, adverse event reporting, regulatory submissions, and global in vitro diagnostics requirements.
विवरण
- Represent Regulatory Affairs on assigned cross-functional project teams.
- Develop regulatory strategies for domestic and international markets by interpreting applicable regulations.
- Plan and carry out regulatory work for complex projects, including new products and existing marketing authorizations.
- Prepare printed and electronic packages for regulatory agency submissions.
- Advise on labeling, manufacturing, and analytical and clinical study plans to support compliance.
- Review validation, clinical, and stability protocols and reports for submission readiness.
- Evaluate manufacturing and labeling changes for regulatory reporting and compliance implications.
- Set, track, and receive submission deliverables.
- Draft and edit submission documents using existing regulatory templates or developing new ones.
- Compile paper and electronic submission copies.
- Track new and updated regulatory requirements and share relevant information.
- Work with regulatory agencies and third-party accrediting organizations.
- Develop internal procedures to support ongoing process improvement.
- Provide regulatory guidance and training to external departments and partners.
- Support adverse event reporting, field actions, recalls, post-market surveillance, and regulatory assessments for marketed in vitro diagnostic products.
आवश्यकताएँ
- At least 5 years of related experience with a bachelor's degree, 3 years with a master's degree, or a PhD; equivalent work experience may also qualify.
- Five or more years of Regulatory Affairs experience preferred.
- Experience at an in vitro diagnostics company preferred; experience in pharmaceuticals, biologics, or medical devices is an acceptable alternative.
- Strong understanding of FDA regulations required.
- Knowledge of regulatory requirements in the EU, Canada, Australia, Japan, and China preferred.
- Able to work independently with new and complex technologies and produce professional work products.
- Strong written and verbal communication skills.
- Team leadership skills preferred.
- Familiarity with office automation software and corporate database tools.
- Strong work ethic and ability to complete assignments on time.
- Must be eligible to work without visa sponsorship.
लाभ
- Variable cash compensation through a bonus or commission program.
- Equity for eligible roles.
- Access to genomics sequencing.
- Family planning benefits.
- Health, dental, and vision coverage.
- Retirement benefits.
- Paid time off.
- Employee Resource Groups with career development, cultural awareness, and social responsibility opportunities.