Address
Form of workCompliance Specialist: Performs the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards. Collaborates with clients to develop positive and proactive approaches to regulatory compliance. Participates in good laboratory practices training of functional areas and assists in the development of training sessions. Ensures that privacy and security standards are met and adhered to. May coordinate activities and assist with interactions during regulatory agency inspections. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. Assists with the corrective action implementation. May coordinate investigator site and clinical supplier vendor audits.
o Focus will be on EMUDR regulations
o Need someone experienced in the EMUDR regulation already
o Main area will be in quality systems and audit compliance.
o Looking for someone who is familiar with quality systems, gap analysis, creating and revising procedures and experience in other regulations will be helpful.
o Any experience doing regulation transition is helpful.
o Experience preparing and hosting audits and external and internal will be helpful.
TOP THINGS MANAGER WOULD LIKE TO SEE ON RESUMES:
1. Knowledge of EMUDR regulation-This is a must
2. Someone who has very familiar with the regulation.
3. Working on transition of the quality system, Project Planning in a quality system.
4. Audit Experience -either a certified auditor or familiar with auditing or qualified auditors.
o Should have at least 1 years of working with EUMDR
o At least 3-5 years experience in Quality
o Industry: Medical device experience is a MUST
o Wanting to move on these roles ASAP. Manager is doing audits the next 3 weeks, but will try to squeeze in the interviews.
o Would like to have a candidate identified by 10/5 and a start date right after.
o Interview Process: Zoom and then work will be remote.
o All work will be remote, entire duration can be all remote.
o Open to non local candidates as long as they can work
o Minimum BA degree Science preferred or something in the medial field.
o MA not required but any sort of technical training, cerification (audit) is a plus.
o Willing to accept someone who has less experience if they do have EUMDR experience.
o Positions are 2 different pay rates because 1 would be more of a Jr. Level Position.
o Looking for people who are hands on with EUMDR in currently role or a previous roles or someone who has stayed on top of regulations by going to seminars, taking classes etcSomeone who is self motivated and self learning is a big asset.
o EUMDR- The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. ... EU MDR is relevant to any organization producing or supplying medical device products to Europe.
o Would look for people in the following areas: Quality Systems project Manager, Regulatory Affairs.
o Manager would consider Senior Level Candidates.
o Will create transition plans document and work with cross functional teams to work with core project team.
o Will create and review documents in the electronic system and read a lot of procedures.
o Team Size: Currently have 4 people on team and are growing from 2 to 7 people.
o Medical Device experience is a MUST HAVE for both positions.
o Audit Experience: Someone who is familiar and knows how an audit works (expectations on audit and business side and how the interaction takes place) as a minimum.
o Person will not be leading the audit (would be preparing documentation in advance of the audit).
o Soft Skills: looking for someone who is driven, must be independent and can work on their own, can direct documentation in her absence, and can work autonomously, ability to make decision on their own.
o Working Relationships: Must be able to work cross functionally in compliance.
o There will be 2 rounds of interview and will only be interviewing 3-4 candidates.
o Focus will be on EMUDR regulations
o Need someone experienced in the EMUDR regulation already
o Main area will be in quality systems and audit compliance.
o Looking for someone who is familiar with quality systems, gap analysis, creating and revising procedures and experience in other regulations will be helpful.
o Any experience doing regulation transition is helpful.
o Experience preparing and hosting audits and external and internal will be helpful.
TOP THINGS MANAGER WOULD LIKE TO SEE ON RESUMES:
1. Knowledge of EMUDR regulation-This is a must
2. Someone who has very familiar with the regulation.
3. Working on transition of the quality system, Project Planning in a quality system.
4. Audit Experience -either a certified auditor or familiar with auditing or qualified auditors.
o Should have at least 1 years of working with EUMDR
o At least 3-5 years experience in Quality
o Industry: Medical device experience is a MUST
o Wanting to move on these roles ASAP. Manager is doing audits the next 3 weeks, but will try to squeeze in the interviews.
o Would like to have a candidate identified by 10/5 and a start date right after.
o Interview Process: Zoom and then work will be remote.
o All work will be remote, entire duration can be all remote.
o Open to non local candidates as long as they can work
o Minimum BA degree Science preferred or something in the medial field.
o MA not required but any sort of technical training, cerification (audit) is a plus.
o Willing to accept someone who has less experience if they do have EUMDR experience.
o Positions are 2 different pay rates because 1 would be more of a Jr. Level Position.
o Looking for people who are hands on with EUMDR in currently role or a previous roles or someone who has stayed on top of regulations by going to seminars, taking classes etcSomeone who is self motivated and self learning is a big asset.
o EUMDR- The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. ... EU MDR is relevant to any organization producing or supplying medical device products to Europe.
o Would look for people in the following areas: Quality Systems project Manager, Regulatory Affairs.
o Manager would consider Senior Level Candidates.
o Will create transition plans document and work with cross functional teams to work with core project team.
o Will create and review documents in the electronic system and read a lot of procedures.
o Team Size: Currently have 4 people on team and are growing from 2 to 7 people.
o Medical Device experience is a MUST HAVE for both positions.
o Audit Experience: Someone who is familiar and knows how an audit works (expectations on audit and business side and how the interaction takes place) as a minimum.
o Person will not be leading the audit (would be preparing documentation in advance of the audit).
o Soft Skills: looking for someone who is driven, must be independent and can work on their own, can direct documentation in her absence, and can work autonomously, ability to make decision on their own.
o Working Relationships: Must be able to work cross functionally in compliance.
o There will be 2 rounds of interview and will only be interviewing 3-4 candidates.
