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:
Legal & Compliance
Job Sub Function:
Law Business Partners
Job Category:
Professional
All Job Posting Locations:
Danvers, Massachusetts, United States of America, New Brunswick, New Jersey, United States of America, Santa Clara, California, United States of America, Washington, District of Columbia, United States of America
Job Description:
We are searching for the best talent to be a Senior Counsel, Regulatory Law, MedTech.
About MedTech
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
The Johnson & Johnson Global Legal Organization ("GLO") is recruiting for a Senior Counsel, Regulatory Law, MedTech to support Johnson & Johnson MedTech. This position can be based in New Brunswick, New Jersey, Washington, D.C., Santa Clara, California, or Danvers, Massachusetts.
Purpose: This Senior Counsel position is for a regulatory attorney within the Med Tech Legal Team of the GLO. The responsibilities of this Senior Counsel involve providing strategic legal counsel on a wide range of regulatory and compliance issues to support the development and commercialization of innovative MedTech products, services, and solutions, including complex capital and Class III devices.
You will be responsible for:
Advising on legalissuesthroughoutthe medicaldevicelifecyclerelated toregulatorystrategy,clinicalresearch,premarketclearanceand approval,marketaccessand reimbursement,productlaunches,commercialization,advertising and promotion,post-marketsurveillance,andqualitysystem compliance.
Guidingqualityand regulatoryteams on interactionswith regulatorsandprovidinglegalsupportduring regulatoryinspections anddiscussions of potentialfield actions.
Supervisingparalegalreview of United Statespromotionaland educationalmaterialsaspart of a cross-functionalteam.
Advising on interactionswith healthcareproviders,payors,andgovernmentofficialsin compliancewith fraud and abuselawssuch astheU.S.Anti-KickbackStatuteand industrycodessuch asthe AdvaMedCode of Ethics.
Engagingin externalregulatoryand policyinitiativeswith tradeassociationsand Johnson & Johnsonpolicy teams.
Being a member of theMed Tech LegalTeamandcollaboratingwithGLOcolleaguesaround theworld.
Partneringwithhealth carecomplianceand privacycolleagues to assessrisk,develop policies,andconductinternaltraining.
TravelingwithintheUnited Statesup to 10% of thetime.
Qualifications/Requirements:
Have a J.D. or LL.M.with admissiontoand good standing with thebar of one state or theDistrict of Columbia.
Haveatleast 7 years of experiencein the medical devices industry,whileworking at a lawfirm,in a regulatoryagency,and/orasanin-houselawyer.
Experienceadvising clients on U.S.regulatory, compliance, and privacymatters, including advertising and promotion, quality, regulatory strategy, clinical research, and cybersecurity issues.
Experience with data rights, machine learning, Artificial Intelligence (AI), robotics, and Software as a Medical Device is preferred.
Demonstrateexcellentstrategicand analyticalskillsand theability tohelpbusinesspartnersfind creativeandcompliantsolutionstonovelissues.
Bean effectivecommunicatorwith a consultativestyle capable ofinteracting withseniorbusinessleadersand participating on cross-functionalteams.
Have a positiveattitudeand theabilitytoworkcollaboratively withinteamsandwith legal colleaguesand businesspartnersatalllevels of seniority.
Beable to workindependentlyin a fast-pacedenvironment,withglobalteamslocated inmultiple time zones.
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 email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
LI-Hybrid
Required Skills:
Preferred Skills:
Business Agility, Collaboration, Commercial Laws, Compliance Management, Corporate Governance, Dispute Resolution, Lawyering, Legal Documents Preparation, Legal Services, Negotiation, Process Improvements, Representing, Risk Management, Strategic Thinking, Tactical Planning, Technical Credibility
The anticipated base pay range for this position is :
$150,000.00 - $258,750.00
For Bay Area:
$172,000.00 - $297,850.00
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)).
This position is eligible to participate in the Company's long-term incentive program.
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
