Senior Regulatory Affairs Program Lead – Wound Closure, Healing

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Manage the entire lifecycle maintenance and the launch of new products within the Wound Closure and Healing portfolio.

• Offer independent regulatory guidance for strategic planning, pre-marketing activities, and regulatory submissions.

• Oversee submissions of licenses, authorizations, international registrations, and dossiers pertaining to medical devices.

• Act as a representative for Regulatory Affairs on cross-functional teams and serve as a regulatory subject matter expert.

• Identify and gather data necessary for regulatory submissions, including clinical data.

• Provide direction for New Product Development and Lifecycle Change Management initiatives.

• Prepare expert responses to inquiries and correspondence from regulatory agencies.

• Draft, write, and submit FDA submissions, encompassing Q-submissions, IDEs, De Novo, and 510(k)s.

• Prepare and file EU MDR submissions.

• Collaborate on the development and approval of labeling and claims.

• Offer Regulatory Affairs support during both internal and external audits.

• Schedule regulatory deliverable timelines and oversee projects until completion.

• Establish best practices for Regulatory Affairs processes and address complex issues.

• Utilize expert knowledge of applicable guidances, regulations, and standards.

• Identify and tackle regulatory challenges while engaging both internal and external stakeholders.

• Foster a culture of continuous learning, collaboration across functions, and effective communication.

⛳️ Requirements

• A minimum of a Bachelor's Degree from an accredited institution is required.

• At least 6+ years of experience in regulatory affairs or a related field is required; 4+ years with an Advanced Degree.

• Experience in the healthcare products sector, including submissions, is required.

• Clinical development experience is strongly preferred.

• Prior experience with submissions for medium- and high-risk medical devices is preferred.

• A proven history of leadership success is strongly preferred.

• Experience leading multifunctional teams is preferred.

• Prior experience with combination products is preferred.

• Regulatory Affairs Certification (RAC) is desirable.

• Experience in working with and negotiating with regulatory bodies is desirable.

• Ability to work both independently and collaboratively in a team setting to address problems and identify process gaps.

• Strong verbal and written communication skills, with the ability to convey information clearly and accurately to diverse audiences.

• Capability to perform well under deadlines.

• Excellent written and communication skills with fluency in English.

• Good judgment, decision-making, and problem-solving capabilities.

• A motivated self-starter who can work independently and also as part of a team.

• Remote candidates must be willing to accommodate up to 20% travel.

🏝️ Benefits

• Fully remote work options considered on a case-by-case basis.

• Retirement plan (pension).

• Savings plan (401(k)).

• Vacation – 120 hours per calendar year.

• Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees.

• 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.

• Up to 20% travel.