Offer summary

Qualifications:

Bachelor’s degree in a relevant field such as life sciences, biologics, or pharmaceuticals required., Minimum of 8+ years of work experience, with 2-4 years in medical devices preferred., Knowledge of international regulations and standards (e.g., RoHS, REACH) is essential., Preferred qualifications include a Master’s degree in engineering or life sciences and PMP or Regulatory Affairs Certification..

Key responsabilities:

Serve as a technical leader for product environmental compliance projects within the Regulatory Affairs organization.

Lead regulatory strategy and manage processes for compliance, including audits and development of procedures.

Interface with data-focused teams to ensure data integrity and drive continuous improvement in regulatory processes.

Advise management on regulatory changes and their potential impact on projects and compliance.

Job description

Work Flexibility: Remote or Hybrid or Onsite

Stryker is hiring a Regulatory Operations Project Manager, Product Environmental Compliance. This position is Remote, supporting our Endoscopy Division. Preference will be given to candidates in the Western and Central locations of the United States.

What you will do

Serve as a technical leader for the Regulatory Affairs organization, with focus on product environmental compliance projects across the Regulatory Operations function.

Leads regulatory strategy and technical pathways for cross functional and potentially cross divisional projects which serve to improve quality compliance and reduce regulatory risk related to product environmental compliance.
Raise awareness, assess and determine strategy for application of changing or new global regulations.
Stay abreast of upcoming changes and advise management on risks, impact and likely project needs for regulation changes.
Leads others in application of understanding of industry practice, domestic and international regulations and company policies to effectively implement and improve product quality and the quality management system.
Manages process for product environmental compliance including serving as SME in Regulatory, internal and external audits.
Lead multiple business units in development of processes/procedures for and implementation of new or revised regulatory requirements.
Set direction and strategy for regulatory affairs organization and department projects.
Interface with data focused organizations to drive data availability, integrity and trending as necessary for product environmental compliance.
Lead projects that aim to drive continuous improvement in processes, procedures or work of RA or divisional teams.
May own, review and approve non-conformances and planned deviations, review and analyze data for trending purposes.

What you need

Bachelor’s degree in a relevant field such as life sciences, biologics and/or pharmaceutical field required.
A minimum of 8+ years of work experience required .
2-4 years experience in medical device with Bachelors or 1 year of experience with Masters degree, biologics and/or pharmaceutical field desired.
Knowledge of applicable international regulations and standards (RoHS, REACH, etc.)

Preferred

Master’s degree in engineering, life sciences or nursing (mechanical, electrical, industrial, software, biomedical, computer, biology, physics, chemistry)etc.
PMP or related certification.
Regulatory Affairs Certification.
Lead development of process and product protocols and reports.
Lead development of statistical process controls and analyzing data.

$113,900.00 - $186,700.00 USD annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

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.

Required profile