Senior Regulatory Affairs Specialist (Monarch) - MedTech Surgery

Johnson & Johnson • Santa Clara, CA

5h • Hybrid

About The Position

This role supports the Robotics and Digital Solutions business for the Monarch Platform. The Senior Regulatory Affairs Specialist provides regulatory guidance to project teams in strategic planning and related submissions under minimal supervision. The individual is responsible for developing and executing regulatory strategies for new, modified, and currently marketed medical devices. This includes preparing regulatory documentation for submissions to health authorities such as European Notified Body, BSI, European MDR, and FDA. The role involves defining data and information needed for regulatory actions with cross-functional teams and guiding conformance with applicable regulations through best practices for Regulatory Affairs processes, procedures, and systems.

Requirements

• Minimum of a Bachelor’s Degree required
• 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.
• 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.

Nice To Haves

• Advanced Degree strongly preferred
• Field of study in science, biomedical engineering, medical / scientific writing, public health administration is highly desired

Responsibilities

• 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.

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior