FAQs
What is the work mode for the Senior Regulatory Affairs Specialist position?
The work mode is hybrid, requiring a minimum of three days in the office per week.
Where is the onsite location for this position?
The onsite location can be in Cork, Galway, or Clonmel, Ireland.
What are the key responsibilities associated with this role?
Key responsibilities include developing regulatory strategies, coordinating regulatory filings, reviewing technical documentation, assessing device changes for regulatory implications, and supporting regulatory audits.
What educational qualifications are required for this role?
A minimum of a Level 8 Honours Bachelor's Degree (240 credits) in STEM is required.
How many years of experience are needed for this position?
A minimum of 5 years of regulatory affairs or related experience is required.
What specific skills are preferred for the Senior Regulatory Affairs Specialist role?
Preferred skills include strong technical, research, and problem-solving abilities, excellent verbal and written communication skills, and the ability to manage multiple projects effectively.
Is experience with regulatory submissions for the US and EU necessary?
Yes, demonstrated experience authoring or supporting a variety of regulatory submissions such as 510(k)s and MDR Technical Documentation is required.
Does the company promote diversity and inclusion?
Yes, Boston Scientific recognizes that nurturing a diverse and inclusive workplace fosters innovation and is committed to inclusion, equality, and opportunity for all.
What kind of support do employees receive for their career advancement?
Employees are provided with access to the latest tools, information, and training to help them advance their skills and careers.
Are reasonable accommodations available during the recruitment process?
Yes, Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability.