Senior Regulatory Affairs Program Lead (Wound Closure & Healing) - MedTech Surgery

You will be responsible for:

·         Represent Regulatory Affairs on cross functional teams and serve as a regulatory SME on projects, including partnering with other functions to define and obtain data to assist with regulatory submissions.

·         Provide input and guidance during New Product Development and Lifecycle Change Management projects, including regulatory strategy and supporting evidence including clinical data.

·         Prepare expert responses to regulatory agencies' questions and other correspondence.

·         Prepare and submits regulatory information required to obtain timely US and EU market access, including preparation, writing and filing of FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s) and EU MDR submissions.

·         Lead the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.

·         Collaborate in the development and approval of labeling and claims development.

·         Provide Regulatory Affairs support during internal and external audits.

·         Plan schedules for regulatory deliverables on a project and monitors project through completion.

·         Assist in the development of best practices for Regulatory Affairs processes. Provide solutions to complex problems in which data analysis requires an evaluation of intangible variables.

·         Applies expert knowledge of guidances, regulations, and standards relevant to product portfolio.

Functional and Technical Competencies:

·         Leverages deep scientific and technical understanding of regulated products within the scope of responsibility to provide strategic regulatory guidance and support for product development and lifecycle management.

·         Integrates and executes results-oriented Regulatory Affairs strategies aligned with organizational objectives, translating patient, customer, business, and external regulatory insights into focused priorities and taking accountability for outcomes.

·         Defines and prioritizes decision criteria and evaluates available facts, benefits, risks, and Credo considerations to make sound decisions, including in complex or ambiguous regulatory situations.

·         Consistently manages large, complex, and/or ambiguous information from multiple sources and leads disciplined execution with clear priorities, accountability, and urgency to advance project objectives.

·         Proactively identifies and resolves regulatory challenges that could affect project or business outcomes and engages internal and external stakeholders to advance regulatory objectives.

·         Challenges and improves regulatory ways of working, simplifying processes where appropriate while maintaining robust controls and compliance requirements.

·         Promotes continuous learning, effective cross-functional collaboration, and candid, constructive communication to improve decision-making, problem-solving, and execution.

·         Deliver by acting with speed, flexibility, accountability and appropriately managing  priorities to deliver business results.

Qualifications / Requirements:

·         Minimum of a Bachelors Degree from accredited college or university is required, Advanced Degree strongly preferred. Science, biomedical engineering, medical / scientific writing, public health administration field of study desired.

·         At least 6+ years of regulatory affairs or related/equivalent experience (4+ with Advanced Degree) is required.

·         Experience in healthcare products product industry including submissions is required.

·         Experience with clinical development strongly preferred.

·         Previous medical device submission experience for medium and high risk devices is preferred.

·         Demonstrated track record of leadership success is strongly preferred.

·         Experience leading multi-functional teams preferred.

·         Previous experience with combination products is preferred. 

·         RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society is desirable.

·         Experience working and negotiating with regulatory bodies is desirable.

·         Ability to work both independently and in a team environment to problem solve and recognize and find solutions for gaps in processes.

·         Ability to communicate clearly and accurately, both verbally and in writing, to a widely varied audience.

·         Ability to work well under deadlines.

·         Excellent written and communication skills, fluency in English.

·         Good judgement/decision making and problem-solving ability, capable of understanding the impact of decision making.

·         Motivated and an enthusiastic self-starter with the ability to work under own initiatives and as a team player.

The position is preferred to be located in Raritan, NJ or can be remote for the right candidate with up to 20% travel is required.

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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#LI-Remote

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

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