drjobs Staff Regulatory Affairs Specialist Hybrid

Staff Regulatory Affairs Specialist Hybrid

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1 Vacancy
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Job Location drjobs

Flower Mound, TX - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Work Flexibility: Hybrid

We are currently seeking a Staff Regulatory Affairs Specialist to join our Communication Business Unit based Hybrid in Flower Mound TX.

What you will do

As the Staff Regulatory Affairs Specialist you support new product development for both US and OUS global regulatory release through the development and of regulatory strategies in accordance with applicable regulatory requirements. You support the total product lifecycle by assessing changes made to the device postlaunch to determine the regulatory impact of changes. You will also ensure regulatory compliance through the maintenance of regulatory documentation and support review by FDA Notified Bodies and other regulatory bodies. You are viewed as the primary regulatory team resource.

  • Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g. concept development manufacturing marketing) to ensure product compliance

  • Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions

  • Assists in the development of regulatory strategy and updates strategy based upon regulatory changes

  • Evaluates proposed products for regulatory classification and jurisdiction

  • Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization

  • Identifies the need for new regulatory procedures SOPs and participates in development and implementation

  • Helps train stakeholders on current and new regulatory requirements to ensure organization wide compliance

  • Assists other departments in the development of SOPs to ensure regulatory compliance

  • Provides regulatory input and technical guidance on global regulatory requirements to product development teams

  • Provides regulatory information and guidance for proposed product claims/labeling

  • Review collateral material associated with new launches and ongoing product support.

What you need

  • Bachelors degree (B.S. or B.A. required

  • 5 years of working in an FDA regulated industry

  • 4 years of medical device regulatory affairs experience

  • Previous experience with Class I and II Medical Devices


Preferred

  • Bachelors degree in Engineering Biological Sciences or equivalent focus

  • RAC certification or Advanced Degree (Masters in Regulatory Affairs)

  • Previous experience with software Medical Devices

  • Experience interacting with regulatory agencies

  • Demonstrated success in management of global regulatory strategy and submission activities

  • Applied knowledge of FDA and international medical device regulations/standards/directive (i.e. European Medical Device Regulations)

  • Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements

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

Employment Type

Full-Time

Company Industry

About Company

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