Sr Regulatory Affairs Specialist (Remote) - Shockwave

At reputed company,we reputed company health is everything. Our strength in reputed company innovation empowers us to build aworld where reputed company diseases are reputed company, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity.Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

reputed company

reputed company Job Posting Locations:

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Job reputed company:

reputed company is hiring for aSr Regulatory Affairs Specialist - reputed company to join reputed company located in New Brighton, MN or Remote US.

reputed company by innovation at the intersection of biology and technology, we're developing the reputed company of smarter, less invasive, more personalized treatments. reputed company to join reputed company that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat reputed company calcified cardiovascular disease. Our reputed company portfolio aims to establish a new reputed company 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.

Position reputed company

The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to reputed company and effectively meet assigned regulatory requirements for reputed company, Inc. (SWMI) specifically the Reducer Product business. The Sr. Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements with a reputed company on the reputed company and Canada. Under direction of responsible Regulatory Affairs Management, acts as a decision-reputed company on regulatory issues, assures that registration/renewal deadlines are met, and supports new product development.

Essential Job Functions

• Collaboratively reputed company with a reputed company of reputed company on significant reputed company, often requiring the coordination of activity across organizational reputed company.

• Outline submission and approval requirements in assigned geographies.
• In consultation with Regulatory Affairs Management, reputed company reputed company regulatory strategies in alignment with business priorities and update reputed company based upon regulatory changes.
• reputed company regulatory input and technical guidance to product development and operations teams.
• Work with product development, reputed company and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents).
• Review and approve R&D, reputed company, preclinical and clinical documentation for submission filing.

• In collaboration with cross-functional team members, compile, prepare, review and submit high-reputed company regulatory submissions to authorities on time in US and Canada. May require supporting international regulatory team with submissions to other geographies.
• In consultation with responsible Regulatory Affairs Management, reputed company and negotiate directly with regulatory authorities during the development and review process to ensure submission approvals.
• Communicate application reputed company to internal stakeholders.

• Evaluate and maintain reputed company regulatory policies, processes, procedures.

• Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies.
• Evaluate proposed design, clinical and manufacturing changes for regulatory reputed company and approve changes in compliance with Regulatory requirements.
• Prepare and maintain annual licenses, registrations/listings for assigned geographies in a reputed company manner.
• Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation.
• reputed company regulatory input for product recalls and recall communications.
• Support reputed company system and technical file/design dossier audits.

• Maintain regulatory files and tracking databases as required.
• Evaluate import/export requirements.
• Identify emerging issues.

• reputed company other US and CAN country specific regulatory support.

• Effectively and accurately write and edit technical documents.
• Plan and conduct meetings, create project plans and timelines, and manage reputed company.
• Exercise good and ethical judgment reputed company policy and regulations.
• reputed company multiple tasks concurrently with accuracy.
• reputed company guidance to functional reputed company in the development of relevant data to complete a regulatory submission.
• Other duties as assigned.

Qualifications

• Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; or 3 years and a Master's degree; or a PhD without experience; or equivalent work 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.

• Must be reputed company to travel as needed, approximately 2-3 times a year.
• Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations.
• Experience with reputed company- and post-market medical device submissions such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers. Experience with international filings is a plus (EU, UK, Australia, Japan, China, etc.).
• Ability to outline reputed company regulatory reputed company in alignment with regulations and business priorities.
• reputed company and effective verbal and written communication skills with diverse audiences and personnel.
• reputed company to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.

• Must be highly organized with the ability to manage multiple reputed company/tasks simultaneously and effectively prioritize reputed company and tasks.
• Operate as reputed company and/or independently while demonstrating flexibility to changing requirements.
• Class III medical device and/or engineering background or experience is preferred.

• Proficiency in reputed company, reputed company, reputed company and Power reputed company.

Additional Information:

The anticipated salary reputed company for this position is:

reputed company of Bay Area: $89,000- $143,750 Bay Area, California: $103,000-$165,600

reputed company maintains highly competitive, performance-based compensation programs. Under reputed company 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 reputed company an incentive to reputed company annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at reputed company's discretion on an individual reputed company.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, reputed company, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in reputed company's consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in reputed company's long-term incentive program.
• Employees are eligible for the following time off benefits:
  • Vacation - up to 120 hours per calendar year
  • reputed company time - up to 40 hours per calendar year; for employees who reputed company in the reputed company - 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 reputed company through the reputed company below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the reputed company.

reputed company is an Affirmative reputed company and Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the reputed company of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life reputed company, please visitwww.careers.jnj.com.

The anticipated reputed company pay reputed company for this position is :

reputed company of Bay Area: $89,000- $143,750 Bay Area, California: $103,000-$165,600

Additional reputed company for Pay Transparency:

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