Sr Regulatory Affairs Specialist

Job Description

Primary Function of Position:

The Regulatory Lead serves as the primary regulatory representative and Subject Matter Expert (SME) within the functional group. The Regulatory Affairs Lead liaises with cross functional organizations, as well as global regulatory counterparts, focusing on product lifecycle management including supporting ongoing product changes and continuous improvement projects. Regulatory expert and SME on the product group, including classifications, indications, applicable regulatory standards and guidance docs., emerging regulations and regulators/industry perspective for the product group.

Roles & Responsibilities:

Providing regulatory guidance and direction, inclusive of potential risks, to cross-functional business partners and company leadership. Creatively identifies risk-based solutions and strategies for problem solving

Develop and recommend strategies for new product development and changes to products including changes to design, material, labeling, packaging, manufacturing process, and facility.

Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation

Assess the impact of the product/process changes and determine regulatory pathway for US and EU markets

Lead, plan, coordinate, and prepare US regulatory submissions of various types, including US FDA 510(k) premarket notifications, and internal Letters to File , as applicable.

Core team RA functional lead acted as liaison between cross-functional team and international counterparts for ROW regarding the impact of changes and work with international counterparts to coordinate global regulatory submissions/approvals, and implementation roll-out

Provide risk-based guidance and strategic input into projects and issues and help facilitate cross functional alignment and resolution

Provides technical guidance and regulatory training/mentoring to other RA employees and cross-functional teams

Perform other duties as required

Qualifications

Skills, Experience, Education, & Training:

Education: Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Pharmacy preferred. Non-technical degree with equivalent complex medical device experience acceptable

Experience: Minimum 10 years of experience in Medical Device industry with roles showing increasing responsibility and 5+ years of medical device regulatory affairs experience in US and submissions and EU technical documentation with solid knowledge of medical device regulations in regard to end-to-end product lifecycle management

In-depth understanding of US and EU Medical Device regulations

Extensive working knowledge of design controls, risk management, verification and validation, and product labeling requirements/documentation is required

Experience with complex products including mechanical, electrical, and software elements is a plus

Ability to work in a fast-paced environment and handle multiple projects simultaneously

Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions

Team player who seeks to help and learn from colleagues seeing the department success as their own

Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism

Proactively seeks to develop and become well-versed within the regulatory landscape.

RAPS Regulatory Affairs Certification (RAC) is a plus

Additional information

All your information will be kept confidential according to EEO guidelines.

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 COVID-19. Details can vary by role.

Intuitive is an Equal Employment 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.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.