Senior Regulatory Affairs Specialist (Monarch) - MedTech Surgery

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Senior Regulatory Affairs Specialist to support our Robotics and Digital Solutions business. This role will work a Flex/Hybrid schedule and be based in the Santa Clara office.  There is NO remote option and relocation assistance is not provided.

The Senior Regulatory Affairs Specialist provides regulatory guidance to project teams in strategic planning and related submissions to support the Monarch Platform under minimal supervision, the individual is responsible for developing and executing regulatory strategies to support new, modified and currently marketed medical devices. This includes the preparation of regulatory documentation for submissions to regulatory health authorities (i.e. European Notified Body, BSI, European MDR, and FDA). The Senior Regulatory Affairs Specialist helps to define data and information needed for regulatory actions in conjunction with cross-functional teams.  He/she guides conformance with applicable regulations through the development of best practices for Regulatory Affairs processes, procedures, and systems. 

You will be responsible for:

• Ensures compliance with regulatory agency regulations and interpretations. 
• Prepares responses to regulatory agencies' questions and other correspondence.
• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
• Provides solutions to a variety of problems of moderate scope and complexity.
• Researches and collects data; and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates. 
• Advises on regulatory labeling requirements specifications for modified products, and reviews product labeling to ensure compliance. 
• Provides regulatory guidance to project teams and responds to product information requests. 
• Provide Regulatory Affairs support during internal and external audits and assist in developing best practices for Regulatory Affairs. 
• Represents Regulatory Affairs on cross-functional project teams. 
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Qualifications / Requirements:

• Minimum of a Bachelor’s Degree required; Advanced Degree strongly preferred. Field of study in science, biomedical engineering, medical / scientific writing, public health administration is highly desired.
• At least 4+ years of related regulatory affairs experience required (3+ with Advanced Degree).
• Experience with healthcare products (Consumer and/or Pharmaceutical and/or Medical Device) industry and regulations is strongly preferred. 
• Knowledge of US (FDA) and OUS (EU MDR) health products regulations is preferred. 
• Previous medical device submission experience is preferred. 
• Ability to work both independently and in a team environment to problem solve and recognize and find solutions for gaps in processes is desirable. 
• Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products (for example, provides regulatory assessments for product recall strategies)
• Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
• Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions.    
• Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.
• Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels. 
• Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with local and/or regional regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives. 
• Lead by leveraging diverse perspectives, backgrounds, and talent to generate effective ideas or solutions. 
• Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances. 

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Process Oriented, Product Packaging Design, Project Management, Project Support, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Risk Assessments, Safety-Oriented

 

 

The anticipated base pay range for this position is :

$106,000.00 - $170,200.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits