Staff Regulatory Affairs Specialist

Portage, WI - USA

Monthly Salary: Not Disclosed

Posted on: 13 hours ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid

We are seeking a Staff Regulatory Affairs Specialist to join our Medical Division - Acute Care in Portage MI (Hybrid).

As a Staff Regulatory Affairs Specialist you will support Strykers global Acute Care portfolio by maintaining market access and ensuring compliance with evolving regulatory requirements. You will assess device changes monitor emerging regulatory intelligence and lead regulatory activities related to wireless technologies. Your work will guide the development approval and compliance of innovative medical devices that incorporate wireless communication.

What You Will Do:

Evaluate device modifications and implement actions to maintain global product compliance.
Analyze emerging regulatory intelligence and advise on potential impact to market access.
Provide regulatory input and technical guidance to product development teams for global requirements.
Determine requirements and options for regulatory submissions approval pathways and compliance activities.
Prepare and submit regulatory submissions in alignment with global regulations and guidelines.
Participate in audits to enable or maintain market access across international markets.
Identify gaps and contribute to development and implementation of new regulatory procedures and SOPs.
Support wireless technology compliance within medical devices to meet global regulatory standards.

What You Need:

Required:

Bachelors degree (B.S. or B.A.) required preferably in Engineering Science or related field.
4 years of experience in a regulated industry required preferably with medical devices.
Previous experience in Pre- or Post-Market Regulatory Clinical Quality or Engineering.

Preferred:

RAC certification or advanced degree (e.g. Masters in Regulatory Affairs).
General understanding of FDA EU and international medical device regulations.

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 contractors legal duty to furnish information.

Required Experience:

Staff IC

Work Flexibility: HybridWe are seeking a Staff Regulatory Affairs Specialist to join our Medical Division - Acute Care in Portage MI (Hybrid).As a Staff Regulatory Affairs Specialist you will support Strykers global Acute Care portfolio by maintaining market access and ensuring compliance with evolv...

Work Flexibility: Hybrid

We are seeking a Staff Regulatory Affairs Specialist to join our Medical Division - Acute Care in Portage MI (Hybrid).

What You Will Do:

Evaluate device modifications and implement actions to maintain global product compliance.
Analyze emerging regulatory intelligence and advise on potential impact to market access.
Provide regulatory input and technical guidance to product development teams for global requirements.
Determine requirements and options for regulatory submissions approval pathways and compliance activities.
Prepare and submit regulatory submissions in alignment with global regulations and guidelines.
Participate in audits to enable or maintain market access across international markets.
Identify gaps and contribute to development and implementation of new regulatory procedures and SOPs.
Support wireless technology compliance within medical devices to meet global regulatory standards.

What You Need:

Required:

Bachelors degree (B.S. or B.A.) required preferably in Engineering Science or related field.
4 years of experience in a regulated industry required preferably with medical devices.
Previous experience in Pre- or Post-Market Regulatory Clinical Quality or Engineering.

Preferred:

RAC certification or advanced degree (e.g. Masters in Regulatory Affairs).
General understanding of FDA EU and international medical device regulations.

Travel Percentage: 10%

Required Experience:

Staff IC

Key Skills

Athletics
Corporate Banking
Dreamweaver
Facilities
IT Support

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About Company

Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more

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