Head of Regulatory
Job Type: Full-time, Permanent
The role will suit an individual who can quickly build professional working relationships, work within a team across all functional units, and enjoys working in an agile environment.
You will have oversight of all Regulatory matters and the Quality Management System to ensure continuous adherence to appropriate standards and regulatory requirements.
Key Duties & Responsibilities
- Executive responsibility for all Ultromics Regulatory matters
- Primary contact point for FDA
- Determine all regulatory compliance requirements and related issues
- Plan and coordinate all aspects of the Ultromics’ Regulatory Compliance
- Oversight of the Quality Management System
- Oversee the Audit process and ensure appropriate corrective actions are implemented where necessary
- Liaise with FDA, Notified Bodies and other Regulatory Authorities
- Manage the Regulatory team and budget
- Direct the development and training of cross functional teams in all aspects of QMS
- Act as management representative
- This list of duties is not exhaustive and the post holder may be asked to carry out other duties through discussion with their line manager
- Primary Degree in a scientific or technical discipline
Evidenced by certificates
Skills and abilities
- Technical File (CE Mark) preparation
- Implementing and ensuring timely completion of CAPAs arising from internal or external audits.
- Excellent communication and interpersonal skills.
- Ability to work collaboratively with stakeholders from diverse functional units.
- Ability to interpret international Regulatory Requirements, apply them to our innovative field of business and embed them in the organisation
Evidenced by CV, interview
- 5 years’ experience in a similar role
- Proven track record in ensuring compliance with ISO13485: 2016, Medical Device Directive (93/42/EEC)/ Medical Device Regulations (MDR), and FDA 21 CFR Part 820
- Experience of Risk Management techniques compliant with ISO 14971
- Has experience with managing QMS projects, providing training and coaching for all quality and regulatory related tasks
- Demonstrate a proven track record at C-suite level
Evidenced by CV, interview
Ultromics is committed to promoting work-life balance and offers a range of benefits to encourage this, including:
- Flexible working hours between 7am-7pm
- Remote working days
- Bonus scheme
- Share option scheme
- Life assurance
- Two additional paid Company holidays in December
- Fitness-incentive benefit (receive £250 back every 6 months for fitness-related activities outside the home)
- Company-wide events (COVID-permitting)
- 5% Company pension contribution
- Sabbatical policy
- Employee referral reward
We are an equal opportunities employer and positively encourage applications from suitably qualified and eligible candidates. Entry into employment and progression within employment will be determined only by personal merit and the application of criteria which are related to the duties of each particular post and the relevant salary structure. In all cases, ability to perform the job will be the primary consideration. No applicant or member of staff shall be discriminated against because of age, disability, gender reassignment, marriage or civil partnership, pregnancy or maternity, race, religion or belief, sex, or sexual orientation.
If you’re selected for an interview and have special requirements due to a disability please let us know so that we can make any necessary adjustments.
Information Security Compliance
By applying for this position, you are confirming that you will be required to comply with Ultromics’ Information Security Policies if you are hired for this role.
Reports to: CEO
Has reports: Yes
The deadline for submitting an application is 30/09/2020 but the advert may close early if a suitable candidate is found.
Application deadline: 30/09/2020
Job Types: Full-time, Permanent
Salary: £110,000.00 per year
- Monday to Friday
- Temporarily due to COVID-19
How to Apply
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