Principal Regulatory Affairs Specialist
Principal Regulatory Affairs Specialist
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$ 105000 - 169050
1 Vacancy
Job Description
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Santa Clara California United States of AmericaJob Description:
Johnson & Johnson is hiring for aSenior Regulatory Affairs Specialist (Remote) Shockwave to join our team.
This is a remote role in the United States. While specific cities are listed in the Locations section for reference please note that they are examples only and do not limit your application.
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 by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
The Principal Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI) specifically the Reducer product business. The Principal Regulatory Affairs Specialist combines knowledge of scientific regulatory and business issues to ensure that products are developed manufactured and distributed to meet regulatory requirements. Under direction of responsible Regulatory Affairs Management works independently with minimal oversight acts as a decision-maker on regulatory issues assures that registration/renewal and other deadlines are met and supports new product development as assigned.
Essential Job Functions
- Collaboratively interface with a variety of levels on significant matters often requiring the coordination of activity across organizational units
- Develop regulatory policies processes and SOPs and may train key personnel on them
- Develop regulatory strategies and update strategy based upon regulatory changes
- Determine submission and approval requirements in assigned geographies and effectively communicate application progress to internal stakeholders
- Provide input and technical guidance on regulatory requirements to product development and operations teams
- Work with product development quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g. ISO and IEC standards REACH ROHS applicable sections of 21 CFR regulatory agency guidance documents)
- Review and approve R&D quality preclinical and clinical documentation for submission filing
- In collaboration with cross-functional team members compile prepare review and/or submit regulatory submissions to authorities and coordinate/communicate with distributors and other agencies for filing purposes mainly focused outside the US as assigned
- Interact and negotiate with distributors authorized reps in-country staff and directly with regulatory authorities during the submission and review process to ensure submission approvals
- Evaluate proposed design clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements
- Oversee the process for preparation and maintaining annual licenses registrations/listings for assigned geographies
- Support product safety evaluation and reporting (e.g. MDR/Vigilance) as required by country regulation
- Provide regulatory input for product recalls and recall communications
- Review and approve advertising and promotional materials to ensure regulatory compliance
- Evaluate import/export requirements
- Identify emerging issues
- Provide other country specific regulatory support
- Effectively and accurately write and edit technical documents
- Plan and conduct meetings create project plans and timelines and manage projects
- Exercise good and ethical judgment within policy and regulations
- Perform multiple tasks concurrently with accuracy
- Provide guidance to functional groups in the development of relevant data to complete a regulatory submission
- Other duties as assigned.
Requirements
- Typically requires a minimum of 10 years of related experience with a Bachelors degree; or 8 years and a Masters degree; or a PhD with 4 years experience; or equivalent experience.
Degree in science math engineering medical or other technical fields and Class III medical device experience are preferred.
- Ability to work collaboratively in a fast-paced environment while managing multiple priorities.
- Detailed working knowledge of applicable domestic and international regulatory guidelines policies and regulations.
- Experience with pre- and post-market medical device submissions such as 510(k) IDE PMA EU Technical Files Design Dossiers and international filings (TGA Health Canada Shonin CFDA etc.)
- Ability to outline sound regulatory strategy in alignment with regulations and business priorities.
- Think analytically with good problem solving skills.
- Effectively negotiate internally and externally with regulatory agencies.
- Clear and effective verbal and written communication skills with diverse audiences and personnel.
- Knowledge of business functions and cross group dependencies/ relationships.
- Leadership of functional groups in the development of relevant data to complete a regulatory submission.
- Ability to follow scientific arguments identify regulatory scientific data needs and solve regulatory issues.
- Operate as a team and/or independently while demonstrating flexibility to changing requirements.
- Some medical device software engineering background or experience is preferred.
- Proficiency in MS Word Excel and Power Point required.
The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance.
- Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Companys long-term incentive program.
- Employees are eligible for the following time off benefits:
- Vacation up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year
- Holiday pay including Floating Holidays up to 13 days per calendar year
- Work Personal and Family Time - up to 40 hours per calendar year
- Additional information can be found through the link below. compensation and benefits information set forth in this posting applies to candidates hired in the United States.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.
The anticipated base pay range for this position is :
$105000-$169050Additional Description for Pay Transparency:
Required Experience:
Staff IC
Employment Type
Full-Time
