Senior Regulatory Affairs Specialist (Monarch) - MedTech Surgery

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