Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Provide support to the Instrumentation & Accessories team within the OTTAVA robotics group.

• Assist Robotics & Digital Solutions in achieving regulatory approval goals for new product development both in the US and internationally.

• Address the regulatory affairs requirements for the robotics, instruments, and accessories portfolios.

• Collaborate with engineering and clinical teams throughout the product development phases.

• Create documentation that is ready for submission and prepare regulatory submissions.

• Facilitate communication with health authorities.

• Engage in the development of regulatory strategies.

• Execute regulatory strategies for obtaining clearances and approvals for new products.

• Prepare, draft, and submit FDA filings, such as 510(k)s, along with technical submissions to global health authorities.

• Identify challenges, communicate project timelines, and tackle issues that may impact registration status.

• Provide guidance to ensure compliance with regulations and guidance documents relevant to product development, claims, labeling, and promotional materials.

• Aid in the establishment of Regulatory Affairs processes.

⛳️ Requirements

• A minimum of a Bachelor's Degree is required; preferred fields of study include Science, Engineering, or a related discipline.

• At least 4+ years of relevant experience in Regulatory Affairs within the Medical Device sector is required; 3+ years with an Advanced Degree.

• Proven experience with regulatory submissions for new medical devices is required.

• A demonstrated history of developing and implementing regulatory strategies is essential.

• Familiarity with the impact of global regulations on product registration is necessary.

• Strong communication skills are needed for effective collaboration with cross-functional partners.

• Capability to correspond and work with J&J colleagues on a global scale.

• Ability to assess new regulatory requirements and changes and evaluate their business implications.

• Exceptional verbal and written communication skills; keen attention to detail is crucial.

• Highly organized with the ability to manage multiple projects/tasks and prioritize effectively.

• Strong aptitude for learning complex technologies and the ability to present intricate regulatory strategies clearly.

• Willingness to travel up to 25% of the time is required.

• Previous experience with health authority meetings and interactions is preferred.

• Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements is preferred.

🏝️ Benefits

• 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 employees; 56 hours for Washington employees.

• 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 per 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.