Senior Regulatory Affairs Specialist – Wound Closure, Healing

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

📋 Description

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

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

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

• Ensure adherence to regulations and interpretations set by regulatory agencies.

• Prepare answers for questions and correspondence from regulatory agencies.

• Collect and organize submission information in line with regulations and guidelines.

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

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

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

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

• Represent Regulatory Affairs in cross-functional project teams.

• Assess regulatory impacts on products and contribute to regulatory strategies and lifecycle management.

• Support complex projects, prioritize deliverables, and resolve regulatory challenges.

• Collaborate across various functions and levels to further regulatory goals.

• Enhance and streamline Regulatory Affairs processes while ensuring control and compliance.

⛳️ Requirements

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

• A minimum of 4+ years of experience in regulatory affairs or a related field is required; at least 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 a plus.

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

• Strong verbal and written communication skills, capable of conveying information clearly to a diverse audience.

• Proven ability to thrive under deadlines.

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

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

• Ability to take initiative and be an effective team player.

• Remote work in the United States available for the right candidate, with up to 10% travel 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.

• Up to 10% travel.