• Staff Regulatory Affairs Specialist Jobs in United States Of America - 25363852

  • STRYKER INDIA
  • United States Of America, Usa
  • Save Job
  • 5 - 8 Years
  • Posted : above 1 month

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 Staff Regulatory Affairs Specialist to join our Medical Division to be located in Kalamazoo, Michigan

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 a Staff Regulatory Affairs Specialist 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 with other devices or external networks

Pre-Market Develop regulatory strategy and communicate with responsible personnel on regulatory requirements for clinical studies and/or marketing applications, evaluation of regulatory filing strategies, and assessment of resulting documentation for compliant with regulatory and corporate requirements
Coordinate and execute pre-approval compliance activities and the preparation, review, and submission of regulatory filings
Monitor impact of changing regulations, develop and implement plans for continued compliance
Assist in the development and implementation of systems and processes in order to maintain and enhance regulatory compliance
Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval
Participate in internal/external audits
Conduct regulatory review and approval of engineering change orders, CAPA/nonconformance, and related project documentation

Post-Market Ensure compliance with product post-marketing approval requirements
Review and approve advertising/promotional items, product labeling, and product claims to ensure compliance with regulatory requirements
Identify product-associated problems and develop proposals for solutions
Assist in the development and implementation of systems and processes in order to maintain and enhance regulatory compliance
Provide regulatory input to support compliant resolution of production issues
Participate in internal/external audits
Conduct regulatory review and approval of engineering change orders, CAPA/nonconformance, and related project documentation

What you need

Bachelors degree in Engineering, Biological Sciences or equivalent scientific area preferred
5 years of Regulatory Affairs experience with 3 years in an FDA regulated industry
Ability to understand and explain detailed regulatory compliance programs 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 judgement
Demonstrated analytical, writing and organizational skills
Demonstrated interpersonal, written and oral communication skills

You may also have

Software-related regulatory experience (eg IEC62304, FDA Software/Cybersecurity Guidance documents, SaMD, Medical Mobile Apps, Cloud based solutions, privacy, PII, PHI)
Regulatory Affairs Certification (RAC) or advanced degree (Masters in Regulatory Affairs)

Work From Home Occasional

Travel Percentage 10 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 : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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