Barrington James
Regulatory Affairs Specialist – Medical Devices
(EU MDR, Swiss MepV, Post-Market & Technical Documentation)
We are seeking a
Regulatory Affairs Specialist
to support and maintain regulatory compliance for a portfolio of
medical devices
across
Europe and Switzerland . This role will play a key part in managing
technical documentation, regulatory submissions, and post-market regulatory activities , working closely with internal teams and external stakeholders. Key Responsibilities
Maintain and update
regulatory and technical documentation
in line with
EU MDR, Swiss MepV, and legacy MDD Prepare, review, and manage
technical files , including labelling, IFUs, UDI data, and risk management documentation Assess and implement
product and documentation changes , ensuring ongoing regulatory compliance Register
economic operators and medical devices
in applicable regulatory systems and manage updates Monitor regulatory, standards, and guidance changes, assess their impact, and communicate updates internally Prepare and submit documentation to
Notified Bodies
and manage responses to regulatory queries Track and maintain regulatory approvals, certificates,
Declarations of Conformity , and
EC-REP / CH-REP
documentation Support
post-market regulatory activities , including PMS documentation, PSURs, PMCF, vigilance, FSCAs/FSNs Collaborate with
Quality, Supply Chain, subcontractors, and external partners
across the product lifecycle Support
internal and external audits
and ensure proper version control and document archiving Required Experience & Skills
Experience in
Regulatory Affairs within Medical Devices Strong working knowledge of
EU MDR Hands‑on experience with
technical documentation and post‑market activities Experience interacting with
Notified Bodies
and regulatory authorities Understanding of
PMS, vigilance, PSUR, PMCF , and change management processes Strong organisational skills and attention to detail Ability to work cross‑functionally in an international environment Fluency in
German Nice to Have
Experience with device registrations and regulatory databases Exposure to audits and inspections Experience working with
EC-REP / CH-REP
arrangements Working Arrangement
This is a
permanent, remote‑based position
with
occasional travel
as required. If you’re interested in learning more, feel free to reach out or apply below:
#J-18808-Ljbffr
Regulatory Affairs Specialist
to support and maintain regulatory compliance for a portfolio of
medical devices
across
Europe and Switzerland . This role will play a key part in managing
technical documentation, regulatory submissions, and post-market regulatory activities , working closely with internal teams and external stakeholders. Key Responsibilities
Maintain and update
regulatory and technical documentation
in line with
EU MDR, Swiss MepV, and legacy MDD Prepare, review, and manage
technical files , including labelling, IFUs, UDI data, and risk management documentation Assess and implement
product and documentation changes , ensuring ongoing regulatory compliance Register
economic operators and medical devices
in applicable regulatory systems and manage updates Monitor regulatory, standards, and guidance changes, assess their impact, and communicate updates internally Prepare and submit documentation to
Notified Bodies
and manage responses to regulatory queries Track and maintain regulatory approvals, certificates,
Declarations of Conformity , and
EC-REP / CH-REP
documentation Support
post-market regulatory activities , including PMS documentation, PSURs, PMCF, vigilance, FSCAs/FSNs Collaborate with
Quality, Supply Chain, subcontractors, and external partners
across the product lifecycle Support
internal and external audits
and ensure proper version control and document archiving Required Experience & Skills
Experience in
Regulatory Affairs within Medical Devices Strong working knowledge of
EU MDR Hands‑on experience with
technical documentation and post‑market activities Experience interacting with
Notified Bodies
and regulatory authorities Understanding of
PMS, vigilance, PSUR, PMCF , and change management processes Strong organisational skills and attention to detail Ability to work cross‑functionally in an international environment Fluency in
German Nice to Have
Experience with device registrations and regulatory databases Exposure to audits and inspections Experience working with
EC-REP / CH-REP
arrangements Working Arrangement
This is a
permanent, remote‑based position
with
occasional travel
as required. If you’re interested in learning more, feel free to reach out or apply below:
#J-18808-Ljbffr