Sr Manager Regulatory Affairs
Sr Manager Regulatory Affairs
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Salary Not Disclosed
1 Vacancy
Job Description
Primary Function of Position
As Senior Manager Regulatory Affairs you will lead and manage a team responsible for developing and executing regulatory strategies within the Multiport Business Unit. Your role includes ensuring compliance with global regulations for product lifecycle management while mentoring and retaining regulatory professionals to foster a highperformance team. You will collaborate with senior leadership to align regulatory efforts with business goals and drive improvements in regulatory processes to support Intuitive s innovation.
Essential Job Duties
- Lead and manage the regulatory affairs team within the Multiport Business Unit providing strategic and technical guidance to ensure compliance with global regulatory requirements.
- Develop and execute regulatory strategies for new product introductions and modifications overseeing submissions for the U.S. Canadian and international markets.
- Act as the primary liaison between regulatory bodies and the company facilitating communication to expedite submission reviews and approvals.
- Evaluate and interpret new regulations and guidelines advising senior leadership on potential impacts and necessary compliance actions.
- Coordinate and lead the preparation of regulatory submissions including 510(k) premarket notifications Presubs and Canadian license applications.
- Provide regulatory expertise during product development and design control ensuring that documentation such as risk management and test reports meet regulatory standards.
- Mentor and develop regulatory affairs staff fostering a culture of continuous improvement and professional growth within the team.
- Collaborate with crossfunctional teams including R&D quality and manufacturing to align regulatory strategies with business objectives and facilitate successful project .
- Identify and mitigate regulatory risks developing contingency plans to address potential compliance issues.
- Stay abreast of industry trends and regulatory changes integrating new knowledge into strategic planning and operational practices.
- Perform other duties as required contributing to the overall success of the regulatory affairs function.
We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.
Base Salary Range Region 1: $176000 USD $264000 USD
Base Salary Range Region 2: $149600 USD $187000 USD
Shift: Day
Workplace Type: Set Schedule This job will be onsite weekly the percentage of onsite work will be defined by the leader.
Qualifications :
Skills Experience Education & Training:
- Minimum 10 years of experience in the medical device industry including significant experience in regulatory affairs and a proven track record in the U.S. presub 510(k) and IDE submissions.
- 35 years of experience as a people manager with demonstrated ability to lead mentor and foster a culture of continuous improvement and professional growth within a team.
- Indepth understanding of U.S. medical device regulations EU MDR and Health Canada regulations coupled with strategic planning and of global regulatory strategies.
- Strong working knowledge of design controls risk management verification and validation processes and product labeling requirements.
- Excellent verbal and written communication and presentation skills with the ability to translate complex technical information into clear regulatory documentation and submissions.
- Strong interpersonal negotiation and influencing abilities capable of engaging with senior leadership and external regulatory bodies to drive initiatives.
- Proactive in professional development and staying informed about regulatory changes with a focus on accuracy completeness and driving results.
Required Education and Training
Minimum B.S. or higher in Biomedical Engineering Electrical Engineering Mechanical Engineering or Pharmacy preferred. Nontechnical degrees with equivalent complex medical device experience are acceptable. Advanced degree in field of study preferred Masters / MBA preferred.
Preferred Skills and Experience
- RAPS Regulatory Affairs Certification (RAC) is a plus.
Additional Information :
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
Mandatory Notices
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
