Senior Regulatory Affairs Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America, Zuchwil, Switzerland

Job Description:

About Orthopaedics

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems.

Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes

We are searching for the best talent for Senior Regulatory Affairs Specialist in

West Chester, PA , Raynham, MA.

JOB SUMMARY

Coordinates, compiles, and submits medical devices applications and investigational medical device applications to the regulatory bodies.

DUTIES & RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

· Leverages scientific and technical understanding of regulated products within scope of responsibility (mainly NPD/NPI) to provide regulatory input to product lifecycle management and evaluate regulatory impact on products.

· Compile, prepare, review, and submit regulatory submission to regulatory authorities.

· Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division orthopedic devices.

· Interface with Product Development to obtain necessary information for regulatory submissions.

· Review / approve Change Requests / Notices to determine the level of change and consequent submission requirements.

· Review/approve product labeling: device labels, brochures, technique guides, bulletins, updates, etc.

· Prepare registration documents, medical device listings, and annual establishment registrations.

· Respond to requests for information on import detentions.

· Maintain regulatory database – ongoing update of database with regulatory information.

· Assist in the development and implementation of SOPs and systems to track and manage product-associated events.

· Develop regulatory strategies and update strategies based upon regulatory changes.

· Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.

· Provide regulatory input to product lifecycle planning.

· Understand, investigate, and evaluate regulatory history / background of class, disease / therapeutic/diagnostic context in order to assess regulatory implications for approval.

· Determine and communicate submission and approval requirements.

· Problem-solve with and advise internal stakeholders on regulatory issues.

· Identify standards for the organization’s products.

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