Senior Regulatory Affairs Specialist - Biosense Webster, Inc.

Biosense Webster , part of Johnson & Johnson MedTech, is current recruiting for a Senior Regulatory Affairs Specialist.

Remote options will be considered on a case by case basis .

Please note : a preferred candidate has already been identified however all qualified applicants will be considered.

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 ...