Regulatory Affairs Specialist – Customer Quality

Stryker - Portage, MI3.9

Full-timeEstimated: $53,000 - $71,000 a year
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 more satisfying lives. We are currently seeking a Regulatory Affairs Specialist (Customer Quality) to join our Medical Division 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

The Regulatory Affairs Specialist, Customer Quality is responsible for determining reportability to the appropriate medical device authority for events that either contributed or could have contributed to adverse events; reviewing and approving investigations and closure of product inquiries; and reviewing and approving of team members' reportability decisions. Additional responsibilities include:

Review and approve investigations
Review complaints and assess them for regulatory reporting (US <30 days, International agencies as appropriate to the regulations)
Handle all necessary complaint handling process activities
Submit initial and follow-up reports to device related Agencies as needed
Interact with device related Agencies on vigilance reports and incidents globally
Work with quality investigators on gathering information for reportability decisions
Utilize Corporate and Division procedures
Assist with training other departments on their complaint handling and reporting responsibilities
May review Ambulance Accident Evaluations and provide communication support to customers regarding policy and process
Prepare and support internal and external audits
What you need

Bachelor’s degree
1 or more years experience in medical devices, biologics or pharmaceutical field preferred
Knowledge of applicable and international regulations and standards preferred
Training and/or certifications in regulatory affairs preferred
Excellent interpersonal skills with the ability to interface with both technical and non-technical personnel at all organizational levels
Excellent written and oral communication.
Excellent organizational, problem-solving, attention to detail, analytical, and time management skills
Work From Home: No
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.