Senior Regulatory Affairs Program Lead – Wound Closure & Healing, MedTech Surgery

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

📋 Description

• Manage the complete lifecycle maintenance and new product launches for the Wound Closure and Healing portfolio.

• Offer independent regulatory advice for strategic planning, pre-marketing activities, and submissions that facilitate global product introductions.

• Oversee submissions for licenses, authorizations, international registrations, and medical device dossiers.

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

• Identify and acquire data necessary for regulatory submissions.

• Direct regulatory strategy and supporting evidence, including clinical data, for product development and lifecycle change initiatives.

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

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

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

• Assist in internal and external audit processes.

• Plan regulatory deliverables and oversee projects until completion.

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

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

⛳️ Requirements

• A minimum of a Bachelor's Degree from an accredited college or university is required.

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

• Previous experience in the healthcare product industry, including submissions, is essential.

• A background in science, biomedical engineering, medical/scientific writing, or public health administration is preferred.

• Strongly preferred experience in clinical development.

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

• A proven track record of successful leadership is highly desirable.

• Experience in leading multi-functional teams is preferred.

• Previous experience with combination products is a plus.

• Regulatory Affairs Certification (RAC) is advantageous.

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

• Capability to work independently as well as collaboratively in a team setting.

• Excellent communication skills, with the ability to articulate information clearly to diverse audiences.

• Ability to perform effectively under tight deadlines.

• Strong written and verbal communication skills; fluency in English is required.

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

• Ability to be self-motivated while also being a team player.

• Remote candidates should be willing to travel up to 20%.

🏝️ Benefits

• Company-consolidated retirement plan (pension).

• Savings plan (401(k)).

• Vacation entitlement of 120 hours per calendar year.

• Sick leave of 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents.

• Holiday pay, including Floating Holidays, totaling 13 days per calendar year.

• Work, Personal, and Family Time – up to 40 hours per calendar year.

• Parental Leave of 480 hours within one year of the birth, adoption, or foster care of a child.

• Bereavement Leave of 240 hours for an immediate family member; 40 hours for an extended family member each calendar year.

• Caregiver Leave of 80 hours within a 52-week rolling period.

• Volunteer Leave of 32 hours per calendar year.

• Military Spouse Time-Off of 80 hours per calendar year.

• Remote work options available on a case-by-case basis.

• Up to 20% travel required for remote candidates.