Senior Manager, Regulatory Affairs
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Job Location:
Mahwah, NJ - USA
Monthly Salary:
$ 155500 - 264500
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Senior Manager Regulatory Affairs Joint Replacement Division
Location: Hybrid Mahwah NJ
As the Senior Manager Regulatory Affairs you will provide leadership and coordination of the Joint Replacement divisions global regulatory strategies submission preparation and approvals for new product launches and patient-specific solutions. You will work across the Regulatory Affairs teams and cross-functional partners with global locations time zones and cultures to achieve market access in alignment with global regulatory requirements.
What You Will Do
Lead development and execution of global regulatory strategies for new product launches ensuring alignment with business objectives.
Manage regulatory submissions for market access including 510(k) PMA and international approvals achieving timely clearances.
Oversee Patient-Specific Solutions regulatory processes to secure custom device approvals through compassionate use pathways.
Direct interactions with health authorities (e.g. FDA EU Notified Bodies) and guide internal teams through regulatory communications.
Monitor and implement new regulatory requirements providing actionable plans to maintain compliance.
Ensure accuracy and completeness of submissions labeling and marketing materials to meet regulatory standards.
Recruit develop and lead a high-performing Regulatory Affairs team setting clear KPIs and performance objectives.
Prepare and manage departmental budgets and forecasts ensuring resource allocation aligns with strategic priorities.
What You Will Need
Required Qualifications
Bachelors degree required. Preferred to be in Engineering Science or related field.
Minimum 10 years of experience in an FDA-regulated industry.
Minimum 5 years of experience in a supervisory or people leadership role.
Experience in the medical device industry required.
Preferred Qualifications
Masters degree or Regulatory Affairs Certification (RAC).
Experience with 510(k) and PMA submissions.
Proven ability to lead geographically dispersed international teams
$155500 - $264500 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.
Posted date: 12.3.25
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:
Senior Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
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
