• Senior Staff Regulatory Affairs Specialist, Jobs in United States Of America

  • United States Of America, Usa

Job Description:

Job Description Stryker is one of the worlds leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives We are currently seeking a Senior Staff Regulatory Affairs Specialist, Software Interoperability to join our Endsoscopy division in San Jose, CA or remotely anywhere within the US

Who we want

Strategic thinkers People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities
Dedicated achievers People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations
Collaborative partners People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions
Self-directed initiators People who take ownership of their work and need no prompting to drive productivity, change, and outcomes

What you will do

As the Senior Staff Regulatory Affairs Specialist, Software Interoperability you will ensure regulatory compliance by completing thorough assessments and the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies Focuses on products with software and/or interoperability with other devices or external networks

Prepare complex submissions to gain global approvals for clinical research, export, and commercial distribution, such as IDE, 510(k), PMA, Shonin, Design Dossier and Technical File
Apply software and security (ie, cybersecurity) regulatory standards, guidance documents, and industry expectations to product strategies and submissions Guides others in the organization who are working on similar products
Interact across corporation or in industry settings to influence software, interoperability and cybersecurity related regulatory items
Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance
Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities
Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review
Lead negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance
Advise personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications
Provide regulatory input to product lifecycle planning
Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions
Review of advertising and promotional items
Assist in SOP development and review

What you need

A Bachelors Degree (BS or BA) in Engineering, Science or equivalent focus is required
A minimum of 7 years of experience in an FDA regulated industry
A minimum of 5 years of Regulatory Affairs experience
Software-related regulatory experience required (eg, IEC62304, FDA Software/Cybersecurity Guidance Documents)
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred
Ability to understand and explain detailed regulatory compliance programs and/or issues
Ability to comply with constantly changing regulatory procedures and prioritize work effectively
Ability to analyze and resolve non-routine regulatory issues using independent judgment
Excellent analytical and writing skills
Excellent interpersonal, written and oral communication skills
Effective organizational skills
Advanced PC skills with proficiency in Microsoft office Suite, including Excel

Work From Home No

Travel Percentage Up to 25 PERCENT

Stryker Corporation is an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status Stryker is an EO employer M/F/Veteran/Disability

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Manufacturing/Industrial, Healthcare
Functional Area : Accounting/Tax/Company Secretary/Audit
Role : Cost Accounting/ ICWA
Salary : As per Industry Standards
Deadline : 18th Mar 2020

Key Skills:

Company Profile:


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