Manager, Regulatory Affairs – Medical Writing – Remote in Mentor OH

Full-time @Steris in Clinical Research , in Finance , in Healthcare , in Medical Device , in Medical Research , in Microbiology , in Risk Management , in Science
  • Mentor, OH, US, 44060 View on Map
  • Apply Before : November 15, 2022

Job Description

Join Steris as Manager, Regulatory Affairs – Medical Writing – Remote in Mentor Ohio. At the Steris you will perform tasks as listed below, Apply Steris Regulatory Affairs careers in Mentor OH.

 

Position : Manager, Regulatory Affairs – Medical Writing – Remote

Job Category: Regulatory Affairs

Work location : Mentor, Ohio

Job Segment : Microbiology, Medical Device, Risk Management, Medical Research, Clinical Research, Science, Healthcare, Finance

 

Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary
The mission of the STERIS Regulatory Affairs function is to implement efficient and effective processes to initially obtain and then maintain clearance to market STERIS products in support of STERIS’s global business plans. This includes meeting registration and/or submission requirements in the US and international markets and working with product acquisition or development teams to ensure these requirements are met. This group also identifies and supports Quality and Regulatory Compliance needs of the Corporation. 

 

This role sits within the Regulatory Affairs group and is focused on development and implementation of clinical evaluation plans and reports with primary responsibility for completion of these critical documents across the international markets in support of STERIS businesses. This individual is consulted by STERIS development teams and business units in support of technical documentation development for a wide range of medical devices.

 

*** This position can be 100% remote. ***

 
Duties

Author high quality Clinical Evaluation documents for new products and maintain/update existing company Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post Market Clinical Follow Up (PMCF) Plans/Reports according to MEDDEV 2.7.1, Rev. 4 – Clinical Evaluation and requirements of the EU Medical Device Regulation (MDR) and related guidance documents.
Manage and develop medical writer staff to ensure clinical evaluation deliverables and milestones are met to achieve regulatory approval and/or maintain compliance. 
Determine the need for and develop and maintain compliant PMCF plans and studies as required according to requirements of MEDDEV 2.12/2 rev. 2 – Post Market Clinical Follow Up and EU MDR clinical evidence needs as necessary.
Evaluate and analyze clinical evidence from clinical investigations, published literature, post-market surveillance, risk assessments, and post-market clinical data to generate appropriate documentation (e.g. CERs or PMCFs) and ensure proper integration with other documentation (e.g., technical files, risk management files) to support regulatory submissions. 
Remain current with both domestic and international regulatory requirements as they relate to clinical evaluations, clinical contributions to regulatory documents, and post-market surveillance requirements.
Lead interactions with various stakeholders (engineering/marketing/regulatory/clinical) to gather information, communicate requirements, and ensure compliance of the clinical evaluation for new devices and updating of CERs for existing devices requiring CE Mark.
Represent the company in interactions with regulatory authorities (e.g. notified bodies, government agencies) to address potential deficiencies during regulatory submissions and/or audits.
Acquire or possess in-depth knowledge of device industry practices, competitor devices, state-of-the-art, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
Maintain thorough knowledge of assigned products using both internal and external resources. 
Perform gap assessments of clinical documents for devices to ensure clinical documentation meets all regulatory requirements.

 

Required Experience
Required:

Bachelor’s Degree in a scientific or clinical discipline (e.g., chemistry, engineering, microbiology, clinical research).
8+ years of total relevant experience in relevant medical device and/or pharmaceutical industry (e.g., regulatory, clinical, medical sciences, R&D, etc.)
2+ years experience in clinical evaluation, medical writing, or writing regulatory submissions
1+ years in managing staff
Write clinical evaluation documentation, including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post Market Clinical Follow Up (PMCF) Plans/Reports.
Knowledge and experience with EU Medical Devices Regulation, MEDDEV 2.7.1, Rev. 4 – Clinical Evaluations, and MEDDEV 2.12-2, PMCF
Excellent written and oral communications skills– strong attention to detail related to consistency, grammar, syntax, and accuracy
Demonstrated ability to work in a team environment, including leading discussions and presenting to internal business and regulatory stakeholders
Ability to identify and mitigate or escalate risks; identify roles/individuals to involve for decision making within clinical evaluation assessment and report development
Ability to prioritize and manage multiple projects and adapt to change as needed
Self-starter attitude with ability to learn quickly and self-educate on different medical device products and procedures; ability to work independently with minimal supervision
Experience in managing staff and/or mentoring junior team members

 

Preferred:

Master’s, Ph.D., or JD is desirable
Knowledge of research methodology (including clinical investigation design and biostatistics) is desirable
Knowledge and experience with ISO 14971 Risk management is desirable

 

Skills

Experience and skill performing systematic medical/ scientific literature searches (PubMed, Google Scholar, EMBASE, etc.)
Excellent written and oral communications skills– strong attention to detail related to consistency, grammar, syntax, and accuracy
Skilled in MS Office (Word, Excel, PowerPoint)

 

Travel:

10-15% Domestic travel required

 
What we offer
The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing competitive salaries, healthcare benefits, tuition assistance, paid-time off, holidays, matching 401(k), annual merit, and incentive plans.  Join us and help write our next chapter.

Competitive pay
Annual merit bonus and incentive plans
Medical, vision, prescription, dental and life insurance
401(k) with a company match
Paid vacation time and paid holidays
On site parking
Tuition assistance
Opportunities for advancement

 

STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics.  We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.

Nearest Major Market: Cleveland

Nearest Secondary Market: Akron

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