Regulatory Affairs Specialist in Sacramento, CA at Stryker Corporation

Date Posted: 11/18/2020

Job Snapshot

Job Description

Stryker is one of the world’s 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 satisfying lives. We are currently seeking a Regulatory Affairs Specialist to join our Sports Medicine Division to be based in Colorado or California.

Who we want

  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 

  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

  • 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. 

  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. 

  • 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 Sports Medicine Regulatory Affairs Specialist, you will support both product development activities for both US and OUS global regulatory release by contributing to the development and updating of regulatory strategy. You will support the entire product lifecycle by assessing post-launch changes to determine the global regulatory impact of changes. You will ensure regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other global regulatory bodies. You will also identify information sources and resources for staying informed of changing local, regional, and global regulations.

  • Address and advise teams on appropriate pathways to market under the supervision of more experienced regulatory professionals.

  • Participate on product development and sustaining engineering teams to ensure appropriate global regulatory requirements are incorporated as part of the development and design change process.

  • Author submissions and other regulatory documents to obtain approval to bring new or modified products to market.

  • Support marketing, R&D and manufacturing teams in regulatory assessment of proposed changes or product transfers; review and approve document action requests.

  • Interface and coordinate with the FDA, Notified Bodies, Competent Authorities and other regulatory agencies on submissions, approvals or other issues under the supervision of more experienced regulatory professionals.

  • Establish and maintain regulatory information systems both electronically and hard copy.

  • Interpret existing and/or new regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnel.

  • Conduct labeling, marketing, product transfer and literature review pre and post market under the supervision of a more experienced regulatory professional.

  • Assist the RA Managers and others with the development, implementation and maintenance of regulatory SOP's.

What you need

  • A Bachelor’s Degree (B.S or B.A) required; Engineering or Science focus preferred.

  • Previous experience with Medical Devices, Regulatory Affairs, Quality or Engineering required.

  • One year of experience in an FDA regulated industry preferably in a Regulatory Affairs, Quality or Engineering role preferred.

  • Excellent interpersonal, written English and oral communication skills.

  • Proficient in Microsoft Office Suite, including Word, Excel and PowerPoint.

  • Knowledge of applicable international regulations and standards (CFR, MDR, QSR, ISO 13485, etc.) preferred.

  • Ability to interface with both technical and non-technical personnel at all organizational levels.

  • 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.

  • Ability to communicate and network with regulatory personnel to obtain relevant information.

  • Regulatory Affairs Certification (RAC) preferred.

#LI-Remote

Work From Home: Remote

Travel Percentage: 10%

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 contractor’s legal duty to furnish information.

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