Senior Regulatory Affairs Specialist - Oxford, United Kingdom - Perspectum

Perspectum
Perspectum
Verified Company
Oxford, United Kingdom

1 month ago

Tom O´Connor

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Tom O´Connor

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Description
Senior Regulatory Affairs Specialist


About the role


The Regulatory Affairs Specialist liaises with the Regulatory Affairs and Quality teams, R&D and Product Management to provide regulatory input into NPI Project Core teams and company operations.


They will assist in correspondence with review agencies, notified bodies, and trade associations on matters relating to product registrations and PMS.

The Regulatory Affairs Specialist will need to liaise with other departments on all cross-functional teams across PD, guide and monitor regulatory compliance in the various countries.


DUTIES AND RESPONSIBILITIES

  • Comprehend relevant standards to the products and services that Perspectum complies with, e.g. IEC 62304, IEC 6236
  • Ensure company quality policies, processes and procedures are conformant to applicable standards and regulations.
  • Comprehension and general maintenance of the Information Security Management system
  • Comprehension and accurate maintenance of the Quality Management System
  • Work with department managers to ensure best practice and drive continuous improvements.
  • Communicate and roll out improved/ new processes and procedures to wider business and external stakeholders.
  • Be able to write partial or parts of technical documentation submissions without supervision.
  • Market monitoring and regulatory research for new target jurisdictions.
  • Assist in maintaining compliance with relevant regulatory legislation and guidelines in various territories Standards and regulations monitoring in the jurisdictions that Perspectum makes devices available on the market.
  • Conduct staff training on regulatory affairs concepts, guidance and regulations.
  • Coordinate the provision of information requested by regulatory authorities.
  • Understand the relevant regulations with regards to the country of registration and support the strategy for market entry together with the relevant internal stakeholders.
  • Identify and coordinate investigations arising from regulatory nonconformities Manage device listings in territories where Perspectum makes devices available in those markets.
  • Manage the transfer of regulatory technical documentation submission process to various territories.
  • Assist in preparation of regulatory technical documentation submissions to various territories.
  • Be able to efficiently communicate Adverse/Reportable Events to regulatory authorities if needed and effectively followup to conclusion for such events.
  • Work with technical and project teams to ensure good data management.
  • Plan and advise other teams to design performance testing to corroborate device performance in line with claims and intended use.
  • Represent regulatory affairs at project team meetings for defined projects, providing information, feedback and strategic advice.
  • Participate in external audits by regulatory authorities.
  • Interface with regulatory reviewers, authorities and authorised representatives through written and oral communications as needed.
  • Plan and implement product change controls in compliance with applicable design controls.
  • Be able to write partial or parts of technical documentation submissions without supervision.
  • Comprehend medical device risk management concepts as per ISO 14971 and write/maintain risk management files.

About Us
At Perspectum, we offer our employees a flexible, fast-paced, and fun environment. We are driven by hiring the best talent, who share our values of excellence, accountability, integrity, openness, and passion.

We value our employees and are constantly striving to ensure we provide a working environment that offers something for everyone, whether that be flexible working, training opportunities or health and wellbeing initiatives.


Benefits include:

  • 33 days annual leave (inclusive of Bank Holidays), increasing with service.
  • Discretionary bonus scheme.
  • Private healthcare including medical referrals, discounts, access to counselling and nutritional support, and cashback on healthcare bills.
  • Share options.
  • Life assurance.
  • Pension contribution rising to 6% after 2 years' service.
  • Sociable working environment including pool table, table tennis and table football.
- £30 per month for gym membership, via GymFlex.

  • Hybrid working we like our employees to be in the office 3 days per week to build those allimportant relationships.
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