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Senior Regulatory Affairs Specialist

Company: Stryker Corporation
Location: Kalamazoo
Posted on: June 6, 2021

Job Description:

About Stryker

Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

What you Will do

Responsible for providing guidance and solutions to ensure that all new products as well as line extensions and legacy product launches meet the requirements of all the markets that the product will be sold into. Working closely with Marketing, Sales and R&D ensure that all regulations are fully understood and project plans reflect these requirements.

Pre-Market:

  • Advice 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.
  • 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.
  • 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.

Regulatory/Quality Compliance

  • Communicate data related to field actions to site and division leadership.
  • Coordinate, analyze, and disseminate field action metrics.
  • Responsible for follow up with division personnel, field action team, and International team members to ensure effectiveness and inquiry responsiveness related to field actions.

What You Need

A Bachelor's Degree (B.S or B.A) required; preferably in Engineering, Science or equivalent focus.

A minimum of 3 years of experience in an FDA or highly regulated industry required.

A minimum of 1 year in a Regulatory Affairs role preferred.

RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

General understanding of product development process and design control preferred.

General understanding of regulations applicable to the conduct of clinical trials preferred.

Previous experience with US Class II/III medical devices preferred.

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

Knowledge / competencies

  • Project management, writing, coordination, and execution of regulatory items
  • Perform technical and scientific regulatory activities
  • Usually works with minimum supervision, conferring with superior on unusual matters
  • Assignments are broad in nature, requiring originality and ingenuity
  • Has some latitude for unreviewed action or decision
  • Seeks out diverse ideas, opinion, and insights and applies them in the workplace
  • Connects and relates well with people who think and act differently than oneself
  • Embraces scrutiny and accepts feedback as opportunity to learn and improve
  • Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources
  • Navigates the dynamics, alliances, and competing requirements of the organization or business
  • Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.

Keywords: Stryker Corporation, Kalamazoo , Senior Regulatory Affairs Specialist, Other , Kalamazoo, Michigan

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