Senior Regulatory Affairs Specialist
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 to product lifecycle management and planning, evaluates regulatory impacts, and develops or updates regulatory strategies. It works with Product Development and other internal stakeholders to gather submission information, address regulatory issues, and determine submission and approval requirements. The position also supports complex projects and makes timely decisions, seeking guidance in ambiguous situations. The role is based in West Chester, Pennsylvania, or Raynham, Massachusetts. Johnson & Johnson has announced plans to separate its Orthopaedics business as DePuy Synthes; following completion of the transaction, the employee is anticipated to join DePuy Synthes, subject to the stated conditions. The position is eligible for the Company’s long-term incentive program. The posting describes time-off benefits, subject to applicable policies and date of hire.
Requirements
- University or bachelor’s degree, or equivalent.
- Generally, 4–6 years of work experience.
- Excellent written and oral communication skills.
- Ability to handle multiple tasks and maintain attention to detail.
- Ability to apply risk-benefit analysis techniques.
Nice To Haves
- Excellent organizational skills.
- Regulatory Affairs Certification (RAC) for Medical Devices.
Responsibilities
- Compile, prepare, review, and submit regulatory submissions to regulatory authorities.
- Monitor applicable reports and submit them, ensuring 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 to determine 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 and update the regulatory database with regulatory information.
- Assist in developing and implementing SOPs and systems to track and manage product-associated events.
- Develop regulatory strategies and update them in response to regulatory changes.
- Provide regulatory input to product lifecycle management and planning.
- Investigate and evaluate regulatory history and the class, disease, and therapeutic or diagnostic context to assess approval implications.
- Determine and communicate submission and approval requirements.
- Advise internal stakeholders and help resolve regulatory issues.
- Identify standards applicable to the organization’s products.
- Support complex projects and make timely, effective decisions to deliver project outcomes.
- Follow applicable laws, company policies, and compliance requirements; participate in compliance-program activities as directed.
- Communicate business-related issues or opportunities to the next management level.
- If supervising or managing staff, ensure subordinates follow applicable Health, Safety, and Environmental practices and have necessary resources.
- Perform other duties as assigned.
Benefits
- Long-term incentive program eligibility.
- Vacation: 120 hours per calendar year.
- Sick time: 40 hours per calendar year, with different stated amounts for employees residing in Colorado or 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, or foster care of a child.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
