Senior Regulatory Affairs Specialist – Wound Closure & Healing

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

📋 Description

• Offer regulatory guidance to project teams for strategic planning and submissions related to Ethicon Wound Closure and Healing products.

• Formulate and implement global regulatory strategies for new, modified, and marketed medical devices.

• Prepare regulatory documentation for submissions to health authorities, including European Notified Body, BSI, European MDR, and FDA.

• Ensure compliance with regulations in product development, claims, labeling, and promotional materials.

• Identify data and information required for regulatory actions in collaboration with cross-functional teams.

• Maintain adherence to regulatory agency regulations and interpretations.

• Draft responses to inquiries and correspondence from regulatory agencies.

• Compile and organize submission information in accordance with regulations and guidelines.

• Conduct research and gather data to address requests from regulatory agencies and distributors.

• Provide advice on regulatory labeling requirements and review product labeling for compliance.

• Offer regulatory guidance to project teams and address product information inquiries.

• Assist in internal and external audits and contribute to the development of Regulatory Affairs best practices.

• Represent Regulatory Affairs on cross-functional project teams.

• Assess regulatory impacts on products throughout their development and lifecycle management.

• Collaborate on effective regulatory strategies that align with business objectives.

• Support complex projects and ensure timely delivery of project deliverables with discipline and accountability.

• Work collaboratively across functions and levels to promote regulatory objectives.

• Enhance and streamline Regulatory Affairs processes while upholding compliance controls.

⛳️ Requirements

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

• At least 4+ years of regulatory affairs or related/equivalent experience is required; 2+ years with an Advanced Degree.

• Experience with healthcare products and industry regulations is essential.

• Familiarity with US and OUS health products regulations is preferred.

• Previous experience with medical device submissions is preferred.

• Capability to work independently as well as part of a team.

• Proficient in clear and accurate communication, both verbally and in writing.

• Ability to perform well under deadlines.

• Excellent written and verbal communication skills.

• Fluency in English is required.

• Strong judgment, decision-making, and problem-solving abilities.

• The position is preferred in Raritan, NJ, or remote in the United States for the right candidate.

• Up to 10% travel may be required.

🏝️ Benefits

• Retirement plan (pension).

• Savings plan (401(k)).

• Vacation – 120 hours per calendar year.

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

• 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.

• Remote work option considered on a case-by-case basis.

• Up to 10% travel.