Fernhollow Medical makes infusion pumps and monitoring devices for hospitals and home care. We are hiring a Regulatory Affairs Specialist to join the Regulatory team.
You will prepare and maintain regulatory submissions and advise product teams on what the rules require. Clear writing and a careful reading of guidance documents are at the centre of the job.
This is a hybrid role based in Boston, with two or three days a week in the office. It is a full-time, permanent position. The pay range for this role is $93,000–$122,000 per year.
This is a fictional posting on the Jobo sandbox. Applications are never sent to a real employer.
What you'll do
- Prepare and maintain regulatory submissions.
- Advise product teams on regulatory requirements early in development.
- Review labelling and promotional material for compliance.
- Track regulatory changes and assess their impact.
- Respond to questions from notified bodies and authorities.
- Maintain technical documentation.
Qualifications
Must have
- Bachelor's in Life Sciences, Pharmacy, Nursing or a related field
- EU MDR
- Regulatory submissions
- Technical documentation
- Clear writing
Nice to have
- RAPS Regulatory Affairs Certification
- FDA 510(k)
- Negotiation
Benefits
- Medical, dental and vision insurance
- 20 days of paid time off plus public holidays
- 16 weeks of paid parental leave
- Team offsites twice a year
- Equipment of your choice