Regulatory Compliance Specialist

X4 Group Ltd
£30k - 40k per year
19 Oct 2016
17 Nov 2016
Contract Type
Regulatory Affairs Specialist / Regulatory Compliance Specialist / RA Specialist / Senior RA Specialist

Location: Manchester

Salary: £30,000 - £40,000 plus competitive benefits

2 new Regulatory Affairs/Compliance focused positions are available see details below. Both positions are brand new opportunities to join a growing and innovative Medical Device Manufacturer on a permanent basis, with the view to bring the right people on as soon as possible.

The positions are Manchester based and would be commutable from Cheshire, Merseyside and Lancashire etc.

Regulatory Compliance Specialist: £30,000 - £40,000 per annum plus company benefits

- Interpret and apply regulations to existing company products to ensure compliance with these regulations in all OUS sites, dealers and distributors.
- Perform audits per published schedules in coordination with divisional and corporate quality compliance teams.
- Participate in global quality compliance teams and support implementation of harmonized procedures.
- Ensure adherence to the company quality audit schedule in international sites.
- Create monthly reports to regional and international management on the status of internal and external audits, open actions, overdue activities and future audits.
- Interface with the company's employees, dealers and distributors regarding quality compliance activities.
- Interact with regulatory agencies in regards to audits and responses until closure.
- Advise and guide management and other personnel in other departments on the interpretation and application of regulations impacting compliance activities.
- Maintain current knowledge of current and proposed regulations, laws, guidelines standards, and initiatives. Assess impact and disseminate throughout the organization for continued regulatory and quality compliance.

Senior Regulatory Affairs Specialist: £30,000 - £40,000 per annum plus company benefits

- Works with Department Head to determine effective regulatory pathways for a variety of issues.
- Participates in ECO process by reviewing ECOs for regulatory filing issues.
- Participates in multi-departmental teams supporting Divisional RA teams in regulatory strategies for submissions by determining and obtaining the necessary information required to support changes to existing products.
- Supports the preparation of FDA submissions, which may include: 510(k)s, IDEs, IDE Supplements, PMAs, PMA Supplements.
- Supports international registration activities.
- Reviews and approves advertisements to assure compliance to international requirements.
- Assists in the complaint program as required.
- Complies with all quality system procedures.
- Reviews technical publications, articles and abstracts to stay abreast of regulatory developments in the industry.

Interviews can be arranged for each position at fairly short notice, therefore, if you are interested, apply by sending your updated CV through to ************************* and call Renee on ************* to discuss in further detail.

Medical Devices / ISO 13485 / FDA / CE Marking / 510K / Regulatory / Technical Files / Risk Management / ISO 14971 / Submissions / Compliance / Lead Audit