Senior Regulatory Affairs Specialist

Johnson & Johnson • West Chester, PA

1d

About The Position

The Senior Regulatory Affairs Specialist coordinates, compiles, and submits medical device and investigational medical device applications to regulatory bodies. The role provides regulatory input across product lifecycle management, primarily for new product development and introduction, and evaluates regulatory impacts on products. It supports orthopedic devices and works with Product Development and other internal stakeholders to secure submission information, address regulatory issues, and determine submission and approval requirements.

The specialist develops and updates regulatory strategies in response to regulatory changes, evaluates regulatory history and context to assess approval implications, identifies applicable standards, and supports complex projects. The position also contributes to regulatory systems and procedures, product-associated event tracking, registrations, product labeling review, and responses to regulatory authorities. It requires sound judgment, risk-benefit analysis, timely decisions, and adherence to applicable laws, company policies, ethics, and compliance requirements.

The position is listed for West Chester, Pennsylvania, and Raynham, Massachusetts. Johnson & Johnson announced plans to separate its Orthopaedics business as DePuy Synthes; following completion of the planned transaction, the employee is anticipated to work for DePuy Synthes under its employment processes, programs, policies, and benefit plans.

Requirements

• University/bachelor’s degree or equivalent.
• Generally, 4–6 years of work experience.
• Excellent written and oral communication skills.
• Ability to handle multiple tasks and be detail oriented.
• Ability to apply risk-benefit analysis techniques.

Nice To Haves

• Excellent organizational skills preferred.
• RAC certification for Medical Devices preferred.

Responsibilities

• Compile, prepare, review, and submit regulatory submissions to regulatory authorities.
• Monitor and submit applicable reports and ensure appropriate responses are provided to regulatory authorities for orthopedic devices.
• Work with Product Development to obtain information needed for regulatory submissions.
• Review and approve change requests and notices, determining the level of change and resulting submission requirements.
• Review and approve product labeling, including device labels, brochures, technique guides, bulletins, and updates.
• Prepare registration documents, medical device listings, and annual establishment registrations.
• Respond to requests for information concerning import detentions.
• Maintain the regulatory database and update it with regulatory information.
• Assist with developing and implementing SOPs and systems to track and manage product-associated events.
• Develop regulatory strategies and update them in response to regulatory changes.
• Support complex projects and make timely, effective decisions to execute project deliverables.
• Provide regulatory input to product lifecycle management and planning.
• Investigate and evaluate regulatory history and the class, disease, therapeutic, or diagnostic context to assess approval implications.
• Determine and communicate submission and approval requirements.
• Advise internal stakeholders and help solve regulatory issues.
• Identify standards applicable to the organization’s products.
• Follow applicable laws and policies and maintain professionalism, ethics, and compliance.
• Participate in compliance program activities as directed by a supervisor or the Chief Compliance Officer.
• Communicate business-related issues or opportunities to the next management level.
• If applicable, ensure managed staff follow company Health, Safety, and Environmental practices and have necessary resources.
• Ensure personal and company compliance with applicable federal, state, local, and company regulations, policies, and procedures.
• Perform other duties as assigned.

Benefits

• Vacation: 120 hours per calendar year, subject to applicable policies and date of hire.
• Sick time: 40 hours per calendar year, with different stated amounts for Colorado and Washington residents.
• 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 a child’s birth, adoption, or foster care placement.
• Bereavement Leave: 240 hours for an immediate family member and 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior