Senior Regulatory Affairs Specialist - Biosense Webster, Inc. - Johnson and Johnson
Irvine, CA 92602
About the Job
About Johnson & Johnson
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Develop regulatory submissions and assessments (in compliance with applicable regulations and standards) to ensure timely global commercialization of products.
DUTIES & RESPONSIBILITIES
Under moderate supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, responsible for the following Regulatory activities:
• Develop and implement regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards.
• Author regulatory submissions and assessments for class II and III medical devices to be distributed in the US to ensure timely global commercialization of products in compliance with applicable regulations and standards.
• Author technical documents for products to be distributed in the EU.
• Prepare international documentation to support product registration internationally.
• Directly communicate with FDA and other Regulatory agencies in preparing responses to submissions and in support of agency audits.
• Evaluate proposed changes to product design or manufacturing processes and assess impact of the proposed changes with regard to worldwide approvals and internal BWI policies and procedures.
• Participate on new product development teams
• Review and approve new product development and product modification documentation.
• Write, review and revise company SOPs as required.
• Communicate business related issues or opportunities to next management level.
• Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Perform other duties assigned as needed. EXPERIENCE AND EDUCATION
• BS degree in Engineering, Physical or Biological science a minimum of 3 years of experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries, OR
• Advanced degree 2 years of experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries.
• Must be familiar with MS Office applications
• Excellent communication skills (verbal and written)
• Project management skills
• Problem solving skills
• Presentation skills
• RAC Certification preferred
• Travel: 10%
• Location: Located in Irvine CA or may work remotely per arrangements with manager
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
The anticipated base pay range for this position is $89,000 to $143,750. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
o Vacation - up to 120 hours per calendar year
o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
o Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below: https://www.careers.jnj.com/employee-benefits
