Senior Manager Regulatory Affairs Mako and Enabling Technologies
Senior Manager Regulatory Affairs Mako and Enabling Technologies
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$ 129600 - 286500
1 Vacancy
Job Description
We are currently seeking a Senior Manager Regulatory Affairs to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). Ideally this role will be hybrid in Mahwah NJ or Weston FL with some workplace flexibility.
As the Senior Manager Regulatory Affairs you will lead and coordinate global regulatory activities including regulatory strategies and health authority submissions to support high impact new product launches ongoing market access and total product life cycle. You will oversee Joint Replacements Mako and Enabling Technologies portfolio which includes robotics navigation capital equipment imaging technology and/or software devices for various orthopedic applications and provides unique opportunities to collaborate across various Stryker divisions. You will confidently and collaboratively work across the RA teams and crossfunctional partners as well as with individuals across international locations and time zones cultures and languages to support global sales growth. You will devote a significant portion of time to managerial leadership and employee development responsibilities ensuring strategic oversight and crossfunctional alignment to meet regulatory requirements.
What you will do
Direct and coordinate activities of experienced Regulatory Affairs professionals to support total product life cycle
Develop and implement regulatory strategies for preparation and submission of regulatory applications and maintenance of internal regulatory file documentation
Collaborate across Stryker divisions and international teams to drive global sales growth
Provide strategic oversight and ensure crossfunctional alignment to meet regulatory requirements
Recruit hire train manage develop and motivate Regulatory Affairs staff
Ensure that departmental Standard Operating Procedures (SOPs) are developed implemented and maintained
Lead communications with health care authorities (e.g. FDA and EU Notified Bodies) and direct health authority interactions with internal teams
Ensure quality and compliance of regulatory submissions labeling and marketing materials
Communicate and collaborate with Quality Assurance R&D Service Global Supply Finance Sales and Marketing departments to ensure corporate goals and strategies are met
What you need
Bachelors degree (B.S. or B.A.
10 years of work experience in an FDA regulated industry
23 years of managerial/supervisory experience
Understanding of global medical device regulations including direct experience with regulatory submissions associated with US and EU Class II/III medical devices
Ability to lead a team collaborate effectively at crossfunctional levels influence others and handle increasing levels of responsibilities
Preferred
Masters degree
RAC Certification
Strong technical knowledge of medical device products
$129600.00 $286500.00 USD salary plus bonus eligible benefits. Actual minimum and maximum may vary based on pay is based on skills experience and other relevant factors.
Travel Percentage: 20Stryker 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
Employment Type
Full-Time
