Associate Director, Regulatory Affairs

Company: Illumina
Location: San Diego
Posted on: February 22, 2021

Job Description:

Responsibilities:

• Participate on product development core teams as regulatory representative
• Interpret and apply regulations by creating regulatory strategies for domestic and international markets
• Prepare hardcopy and electronic information packages for submission to regulatory agencies
• Lead complex regulatory submission teams
• Provide recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance
• Review validation, clinical and stability protocols and reports for regulatory submission soundness
• Assess manufacturing process and labeling changes for regulatory reporting impact
• Define, monitor and receive deliverables for submissions
• Write and/or edit submission documents using regulatory templates, or create new templates
• Participate in Material Review Board and complaint/recall meetings
• Complete health hazard assessments for regulatory reporting of product problems; prepare regulatory agency information packages
• Keep informed of new and revised regulations; disseminate information as directed by management
• Interact with regulatory agencies, maintain correspondence and other records of interaction
• Assemble paper and/or electronic copies for submission
• Prepare internal procedures for continuous process improvement
• Mentor junior members of the department
• Provide regulatory guidance and/or training to external departments and marketing partners
• Assist in hosting inspections, as needed
• Assist in conducting internal/external audits, as needed
• Manage consultants, as needed Experience/Education:
  • Typically requires a BS/BA degree or equivalent and a minimum of 10 years related experience OR MS degree or equivalent and 6 years related experience OR PhD and 4 years related experience.
  • Proven experience with at least 10 years of practice interacting with regulatory agencies dealing with matters of compliance with ISO, FDA, EU and other regulations and standards.
  • Must be detail oriented, well organized, and able to work independently and in teams.
  • Must have excellent interpersonal skills, as well as verbal and written communication skills.At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf Posted 15 Days Ago Full time 22141-JOB About Us Do you want to make a difference? Illumina's mission is to improve human health by unlocking the power of the genome. If that inspires you, let's talk. We've built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. Life at Illumina is about working with teammates who are deeply passionate about what we do, because we know that our work has the power to improve lives. We're an established company with a track record of phenomenal growth. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn't just in financials, we've been busy hiring the best and the brightest. Perhaps that's why MIT has ranked Illumina near the top of its World's Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.

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