Work Flexibility: Hybrid

We are currently seeking a Staff Regulatory Affairs Specialist to join our Instruments division based hybrid two to three days per week in Portage, MI.

Who we want

·         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.

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

What you will do

As the Staff Regulatory Affairs Specialist, you will support new product development for both domestic and international release contributing to the development and updating of regulatory strategy based upon regulatory changes. You will play an integral role ensuring compliance by completing thorough assessments pertaining to product clearances/approval by the FDA, Notified Bodies, and other regulatory bodies.

• Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.

• Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.

• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies

• Develops basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.

• Coordinates and supports technical and scientific regulatory activities.

• Performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility.

• Assists in SOP development & review.

• Stays abreast of regulatory procedures and changes in regulatory climate.

• Maintains records on legislation, relations and guidelines.

• Investigates regulatory history of similar products to assess approval implications.

• Conducts research on submission requirements and options.

• Assists in monitoring and reporting project timelines.

• Responds to RA information requests.

• Monitors and utilizes tracking and control systems.

What you need

• Bachelors Degree required; preferably in Engineering, Science, or related area

• Minimum 5 years of full-time work experience in an FDA regulated environment required

• Minimum 2-4 years of full-time work experience in medical device regulatory affairs required

• Demonstrated applied knowledge of FDA and international medical device regulations/standards (e.g. EU MDR)

• Time management skills, writing, coordination, and execution of basic regulatory items.

Preferred

• MS or RAC(s)

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.