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Senior Counsel, Regulatory Law – MedTech
Johnson & Johnson. Provide strategic legal counsel on regulatory and compliance issues supporting the development and commercialization of innovative MedTech products, services, and solutions, including complex capital and Class III devices.
Core Competencies
Role fitUse this summary to align your resume positioning with the role.
Demonstrates expertise in providing strategic legal counsel on regulatory and compliance issues within the MedTech industry, including advising on U.S. regulatory matters, clinical research, and product commercialization. Possesses strong analytical and communication skills to effectively collaborate with cross-functional teams and senior business leaders.
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Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Provide strategic legal counsel on regulatory and compliance issues supporting the development and commercialization of innovative MedTech products, services, and solutions, including complex capital and Class III devices.
- Advise on legal issues throughout the medical device lifecycle, including regulatory strategy, clinical research, premarket clearance and approval, market access and reimbursement, product launches, commercialization, advertising and promotion, post-market surveillance, and quality system compliance.
- Guide quality and regulatory teams on interactions with regulators and provide legal support during regulatory inspections and discussions of potential field actions.
- Supervise paralegal review of United States promotional and educational materials as part of a cross-functional team.
- Advise on interactions with health care providers, payors, and government officials regarding fraud and abuse laws and industry codes such as the AdvaMed Code of Ethics.
- Engage in external regulatory and policy initiatives with trade associations and Johnson & Johnson policy teams.
- Collaborate with Global Legal Organization colleagues around the world as a member of the MedTech Legal Team.
- Partner with health care compliance and privacy colleagues to assess risk, develop policies, and conduct internal training.
- Travel within the United States up to 10% of the time.
Requirements
What you’ll need- A J.D. or LL.M. with admission to and good standing with the bar of one state or the District of Columbia is required.
- At least 7 years of experience in the medical devices industry, while working at a law firm, in a regulatory agency, and/or as an in-house lawyer.
- Experience advising clients on U.S. regulatory, compliance, and privacy matters, including advertising and promotion, quality, regulatory strategy, clinical research, and cybersecurity issues.
- Experience with complex capital, data rights, machine learning, Artificial Intelligence (AI), robotics, and Software as a Medical Device is preferred.
- Excellent strategic and analytical skills and the ability to help business partners find creative and compliant solutions to novel issues.
- Effective communicator with a consultative style capable of interacting with senior business leaders and participating on cross-functional teams.
- Positive attitude and ability to work collaboratively within teams and with legal colleagues and business partners at all levels of seniority.
- Ability to work independently in a fast-paced environment, with global teams located in multiple time zones.
Benefits
Comp & perks- Retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- 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